MICOR extractor FG-50621Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00860000122368), received between Mar 11, 2021 and Feb 24, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Insufficient Device Problem Information

  A PATIENT WITH A HYPER-MATURE CATARACT AND A HISTORY OF KERATOCONUS AND COLLAGEN CROSSLINKING UNDERWENT CATARACT SURGERY IN THE RIGHT EYE. THE MILOOP LENS FRAGMENTATION DEVICE WAS USED TO SECTION THE CATARACT AND TWO CUTS WERE MADE. THE MILOOP WAS PROPERLY ORIENTED AND WELL CENTERED; HOWEVER, THE DEVICE DID NOT FULLY CIRCUMNAVIGATE THE LENS. WHEN ATTEMPTING TO ROTATE THE MILOOP AND SWEEP, PRESSURE WAS INADVERTENTLY APPLIED TO THE EDGE OF THE LENS, CAUSING PRESSURE AND LENS TILT ON THE OPPOSITE SIDE. THE SURGEON PROCEEDED TO BEGIN LENS REMOVAL USING THE MICOR LENS FRAGMENTATION SYSTEM AND THE LENS SEPARATED INTO TWO HALVES. WHILE WORKING ON ONE HALF, THE OTHER LENS SEGMENT WAS FLOATING ON THE OPPOSITE SIDE AND DROPPED IMMEDIATELY INTO THE POSTERIOR CHAMBER. THE SURGEON CONTINUED REMOVING THE REMAINING LENS SEGMENT USING MICOR WHICH WAS COMPLETED SUCCESSFULLY. THE SURGEON THEN CONVERTED TO PHACOEMULSIFICATION TO PERFORM AN ANTERIOR VITRECTOMY AND IMPLANTED A 3-PIECE INTRAOCULAR LENS IN THE SULCUS. THE NUCLEUS REMNANT WAS LEFT IN THE VITREOUS CAVITY AND THE PATIENT WAS REFERRED TO A RETINA SPECIALIST. THE SURGEON STATED THAT AS PRESSURE WAS APPLIED DURING THE MILOOP PORTION OF THE SUR

  Patient problems: Capsular Bag Tear; Cataract; Foreign Body In Patient; Vitreous Loss

  MAUDE report 24434349 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. A POSTERIOR CAPSULAR TEAR OCCURRED DURING SURGERY AND A PORTION OF THE LENS NUCLEUS FELL POSTERIORLY INTO THE VITREOUS CAVITY. THE NUCLEUS REMNANT WAS LEFT BEHIND FOR THE RETINA SPECIALIST TO ADDRESS AND A 3-PIECE INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS. THE SURGEON WAS UNSURE WHEN THE CAPSULE RUPTURE OCCURRED. PATIENT FOLLOW-UP INFORMATION WAS REQUESTED FROM THE PHYSICIAN'S OFFICE ON THREE SEPARATE OCCASIONS, BUT NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME

  Patient problems: Capsular Bag Tear; Foreign Body In Patient

  MAUDE report 23343408 ↗
• InjurySep 4, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SURGEON PERFORMED HYDRODISTENTION AND USED A MILOOP FOR ONE CUT. DURING NUCLEUS EXTRACTION WITH THE MICOR 700, THE SURGEON ATTEMPTED TO FREE MATERIAL USING A DRYSDALE AS A SECOND INSTRUMENT. WHILE MANEUVERING THE SECOND INSTRUMENT AROUND A NUCLEAR FRAGMENT IN THE PERIPHERY, THE CAPSULE WAS LIKELY PUNCTURED. THE MICOR TIP WAS IN THE MIDDLE OF THE EYE AND NOT NEAR THE COMPROMISED AREA WHEN THE ISSUE WAS IDENTIFIED. UPON RECOGNIZING THE CAPSULE COMPROMISE, THE SURGEON STOPPED ASPIRATION, INJECTED VISCOELASTIC, AND REMOVED THE MICOR DEVICE. AN ANTERIOR VITRECTOMY WAS PERFORMED USING A PHACO UNIT, AND A THREE-PIECE SULCUS LENS WAS IMPLANTED INSTEAD OF THE PLANNED ONE-PIECE LENS. THE SURGEON ATTRIBUTED THE LIKELY CAUSE OF THE CAPSULE PUNCTURE TO THE SECOND INSTRUMENT (DRYSDALE), NOT THE MICOR TIP. PATIENT MOVEMENT DURING THE PROCEDURE, CAUSED BY SIGNIFICANT SHOULDER PAIN (ROTATOR CUFF ISSUES), MAY HAVE BEEN A CONTRIBUTING FACTOR. THE MICOR EXTRACTOR WILL BE SENT FOR EVALUATION, THOUGH IT IS NOT BELIEVED TO BE THE CAUSE OF THE EVENT. THE PROCEDURE LASTED APPROXIMATELY ONE HOUR, AND THE VITRECTOMY WAS COMPLETED SUCCESSFULLY. ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 22965288 ↗
• InjuryAug 1, 2025Suction Problem; Suction Problem

  A PATIENT UNDERWENT FEMTOSECOND-LASER ASSISTED CATARACT SURGERY IN THE RIGHT EYE AND THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. DURING LENS EXTRACTION, A TEAR OCCURRED IN THE CAPSULAR BAG WHILE MANIPULATING ONE OF THE FINAL LENS FRAGMENTS. THE INITIAL MEDIUM-SIZED TEAR BECAME ENLARGED DUE TO BRIEF CONTINUED VACUUM ENGAGEMENT AND THERE WAS VITREOUS LOSS. THE SURGEON INSERTED VISCOELASTIC, REMOVED THE MICOR EXTRACTOR FROM THE EYE, AND CONVERTED TO PHACOEMULSIFICATION. AN ANTERIOR VITRECTOMY WAS PERFORMED WITHOUT INCIDENT. THE ORIGINAL SURGICAL PLAN WAS TO IMPLANT A MULTIFOCAL INTRAOCULAR LENS (IOL) IN THE CAPSULAR BAG; HOWEVER, DUE TO THE INTRAOPERATIVE ADVERSE EVENT, A 3-PIECE MONOFOCAL IOL WAS IMPLANTED. THE LENS WAS WELL-CENTERED AT THE CONCLUSION OF THE PROCEDURE AND THE PATIENT WAS EXPECTED TO HAVE A FAVORABLE OUTCOME. ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON. POSTOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IS 20/30 AND THE PATIENT IS DOING WELL. THE PREOPERATIVE BCVA WAS REQUESTED FOR COMPARISON.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 22693129 ↗
• InjuryJun 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WITH A DENSE WHITE CATARACT (GRADE 3+ OR 4), WEAK ZONULES, AND A DEEP EYE UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2025. THE SURGEON REPORTED EXPERIENCING DIFFICULTY DURING LENS SEGMENTATION AND CHOPPING DUE TO THE CATARACT DENSITY. THE MICOR LENS FRAGMENTATION SYSTEM WAS THEN USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. A MANUAL INSTRUMENT WAS USED TO MANIPULATE ONE OF THE SEGMENTS INTO THE ANTERIOR CHAMBER AND CATARACT EXTRACTION CONTINUED FAIRLY EFFICIENTLY CONSIDERING THE DENSITY. WHEN WORKING ON THE LAST LENS SEGMENT, THE SURGEON MADE THE DECISION TO CONVERT TO PHACOEMULSIFICATION. VISCOELASTIC WAS INJECTED AND 2 CAPSULAR HOOKS WERE USED FOR THE REMAINDER OF THE PROCEDURE AND A CAPSULAR TENSION RING WAS INSERTED TO STABILIZE THE CAPSULE. AT SOME POINT DURING LENS EXTRACTION THERE WAS A SMALL CAPSULAR TEAR, BUT THERE WAS NO VITREOUS FLUID LOSS AND NO VITRECTOMY WAS NEEDED. THE ORIGINAL INTRAOCULAR LENS PLAN WAS TO IMPLANT A TORIC IOL IN THE CAPSULAR BAG; HOWEVER, A 3-PIECE INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS (WHICH WAS DESCRIBED AS FIXATED STRONGLY AND CENTERED PERFECTLY). IN ORDER TO ADDRESS THE CHANGE IN IOL MODEL, LIMBAL RELAXING INCISIONS W

  Patient problems: Capsular Bag Tear

  MAUDE report 22354520 ↗
• InjuryDec 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2024 WHERE THE MILOOP WAS USED TO PRE-SEGMENT THE CATARACT. THE MICOR LENS FRAGMENTATION SYSTEM WAS THEN USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. DURING LENS REMOVAL OF THE LAST LENS FRAGMENT WITH THE MICOR EXTRACTOR THE SURGEON REQUESTED THE VITRECTOR AND PROCEEDED TO PERFORM AN ANTERIOR VITRECTOMY. AN INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS. THERE WAS NO REPORT OF A PROBLEM WITH THE MICOR DEVICE, THE PROCEDURE WAS DESCRIBED AS ROUTINE, AND THE SURGEON WAS USING LIGHT THROTTLE WHEN THE VITRECTOR WAS REQUESTED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN AND SURGERY CENTER ON MULTIPLE OCCASIONS, BUT THERE HAS BEEN NO RESPONSE. THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT REMAINS UNKNOWN.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 20922396 ↗
• InjuryOct 31, 2024Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2024 WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. THE CATARACT SURGERY WAS PERFORMED IN COMBINATION WITH IMPLANTATION OF A GLAUCOMA DRAINAGE DEVICE (GDD) WHERE THE GDD WAS IMPLANTED PRIOR TO LENS EXTRACTION. A MILOOP WAS USED FOR SEGMENTATION OF THE LENS. THE MILOOP WAS INSERTED INTO THE CORNEAL INCISION AND THE SURGEON MADE 2 CUTS WITH THE MILOOP TO SEGMENT THE LENS INTO 4 QUADRANTS. THERE WERE NO PROBLEMS WITH THE MILOOP PORTION OF THE PROCEDURE AND THE CAPSULE WAS INTACT AT THE TIME THE MILOOP WAS REMOVED FROM THE EYE. THE MICOR EXTRACTOR WAS THEN USED FOR LENS EXTRACTION. THE CATARACT WAS DESCRIBED AS DENSE. WHILE REMOVING THE LAST FRAGMENT, THE SURGEON APPEARS TO ENGAGE THE MICOR AT FULL THROTTLE AND A POST-OCCLUSION SURGE IS OBSERVED, WHICH IS IMMEDIATELY FOLLOWED BY A POSTERIOR CAPSULAR BAG TEAR. REVIEW OF SURGICAL VIDEO REVEALED THE TIP OF THE MICOR EXTRACTOR ENGAGED WITH THE POSTERIOR CAPSULE. THERE WAS NO LOSS OF VITREOUS FLUID AND NO VITRECTOMY WAS PERFORMED. THE SURGEON CONTINUED AND COMPLETED LENS EXTRACTION AND IMPLANTED A POSTERIOR CHAMBER INTRAOCULAR LENS A

  Patient problems: Capsular Bag Tear

  MAUDE report 20584934 ↗
• InjuryOct 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2024 WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. THE CATARACT SURGERY WAS PERFORMED IN COMBINATION WITH IMPLANTATION OF A GLAUCOMA DRAINAGE DEVICE (GDD) WHERE THE GDD WAS IMPLANTED PRIOR TO LENS EXTRACTION. THE CATARACT WAS DESCRIBED AS HARD AND THE PUPIL WAS VERY CONSTRICTED. DURING LENS REMOVAL WITH THE MICOR EXTRACTOR THE POSTERIOR CAPSULE TORE AND THERE WAS VITREOUS LOSS AND A PORTION OF THE LENS DROPPED INTO THE VITREOUS CAVITY. A VITRECTOMY WAS PERFORMED AND THE PATIENT WAS REFERRED TO A RETINA SPECIALIST. NO INTRAOCULAR LENS WAS ABLE TO BE IMPLANTED DUE TO LACK OF CAPSULAR SUPPORT. POSTOPERATIVELY THE PATIENT HAD CORNEAL EDEMA AND INFLAMMATION. INTRAOCULAR LENS IMPLANTATION WILL BE PERFORMED AS THE EYE HEALS.

  Patient problems: Capsular Bag Tear; Foreign Body In Patient; Vitreous Loss

  MAUDE report 20584920 ↗
• InjurySep 6, 2024Suction Problem; Suction Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2024 WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. THE SURGEON EXPERIENCED A SMALL HOLE IN THE POSTERIOR CAPSULE DURING IRRIGATION AND ASPIRATION OF CORTEX. THE ANTERIOR HYALOID REMAINED INTACT AND THERE WAS NO VITREOUS FLUID LOSS. SURGICAL TECHNIQUE WAS EMPLOYED APPROPRIATELY, I.E., NOT ALLOWING CAPSULAR BAG TO BOW FORWARD. THE SURGEON ATTRIBUTED THE EVENT TO THE MICOR DEVICE CITING "SNAPPINESS" WHICH IS FURTHER CLARIFIED BELOW. "WHILE THE EVENT WAS ATTRIBUTABLE TO THE FLUIDICS OF THE DEVICE, THE FACT THAT THE [MICOR EXTRACTOR] TIP DOES NOT HAVE SHARP EDGES ALSO CONTRIBUTED TO THE SMALL SIZE OF THE HOLE, THE FACT THAT THE TEAR DID NOT EXTEND, AND MY ABILITY TO PLACE A ONE PIECE TORIC MULTIFOCAL IOL IN THE BAG AS PLANNED. THERE WAS A THIN EPINUCLEAR PLATE [OF THE CATARACT] PRESENT. IN BOTH PHACO[EMULSIFICATION] AND MICOR, WHEN YOU REACH FOR A THIN REMAINING PIECE, THERE IS A RISK OF THE DEVICE BUILDING VACUUM AND POPPING THROUGH THE REMAINING [CATARACT] PIECE AND THEN INTERACTING WITH THE POSTERIOR CAPSULE, THEREBY CAUSING A TEAR. THERE WAS A CLINICAL DECISION MADE TO REACH

  Patient problems: Capsular Bag Tear

  MAUDE report 20164644 ↗
• InjurySep 6, 2024Suction Problem; Suction Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2023 WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. THE MANUFACTURER BECAME AWARE OF THE EVENT APPROXIMATELY 13 MONTHS AFTERWARDS AND ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON WHO PROVIDED A DETAILED ACCOUNT OF THE EVENT (BASED ON SURGICAL VIDEO). THE SURGEON NOTICED SMALL HOLE IN THE POSTERIOR CAPSULE AT END OF IRRIGATION AND ASPIRATION CORTEX REMOVAL. SURGICAL TECHNIQUE WAS EMPLOYED APPROPRIATELY, I.E., NOT ALLOWING CAPSULAR BAG TO BOW FORWARD; HOWEVER, A SMALL AMOUNT OF VITREOUS CAME THROUGH THE HOLE AND WAS REMOVED WITH A VITRECTOR (ANTERIOR VITRECTOMY PERFORMED). THE SURGEON ATTRIBUTED THE EVENT TO THE MICOR DEVICE CITING "SNAPPINESS" WHICH IS FURTHER CLARIFIED BELOW. "THERE WAS A THIN EPINUCLEAR PLATE [OF THE CATARACT] PRESENT. IN BOTH PHACO[EMULSIFICATION] AND MICOR, WHEN YOU REACH FOR A THIN REMAINING PIECE, THERE IS A RISK OF THE DEVICE BUILDING VACUUM AND POPPING THROUGH THE REMAINING [CATARACT] PIECE AND THEN INTERACTING WITH THE POSTERIOR CAPSULE, THEREBY CAUSING A TEAR. THERE WAS A CLINICAL DECISION MADE TO REACH FOR THE REMAINING THIN PIECE THAT CO

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 20164637 ↗
• InjuryAug 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2024 WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. DURING THE PROCEDURE THE MICOR EXTRACTOR TIP CAUGHT THE CAPSULAR BAG DURING CHOPPING AND THERE WAS ZONULAR DIALYSIS. THERE WAS NO CHANGE IN THE TYPE OF INTRAOCULAR LENS (IOL) IMPLANTED COMPARED TO THE SURGICAL PLAN. AND NO DECREASE IN VISUAL ACUITY. THE SURGEON ATTRIBUTED THE EVENT TO A DENSE LENS. THE PATIENT IS DOING WELL AND HAPPY WITH IMPROVED VISUAL ACUITY. THE IOL IS IN THE PROPER POSITION AND THERE HAS BEEN NO POSTOPERATIVE ISSUE.

  Patient problems: Zonular Dehiscence

  MAUDE report 20057888 ↗
• InjuryAug 21, 2024Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Misassembly by Users; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Misassembly by Users

  A PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2024 WHERE THE MILOOP AND MICOR LENS FRAGMENTATION SYSTEM WERE USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS FRAGMENTS. THE MICOR EXTRACTOR NOSE CONE WAS NOT ATTACHED PROPERLY DURING THE NUCLEUS REMOVAL AND THERE WAS INSUFFICIENT IRRIGATION AND THE POSTERIOR CAPSULE RUPTURED. THE SURGEON STATED THAT THE ANTERIOR CHAMBER BOUNCE CAUGHT THE CAPSULE. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON ON (B)(6) 2024. WHILE PERFORMING ASPIRATION OF THE NUCLEAR PIECES, THE MICOR EXTRACTOR NOSE CONE BECAME LOOSE AND SEPARATED FROM THE MICOR EXTRACTOR HANDPIECE. THERE WAS A LOSS OF INTRAOCULAR PRESSURE (IOP) IN THE ANTERIOR CHAMBER AND THE POSTERIOR CAPSULE TOUCHED THE MICOR TIP, FORMING A ROUND HOLE IN THE POSTERIOR CHAMBER WITH VITREOUS FLUID LOSS. VISCOELASTIC WAS INJECTED; HOWEVER, THERE WAS A SECOND LOSS OF IOP IN THE AC DUE TO INSUFFICIENT BALANCED SALT SOLUTION (BSS) AVAILABLE. AT THIS TIME THE POSTERIOR CAPSULAR TEAR EXTENDED AND THE NUCLEUS DROPPED INTO THE VITREOUS CAVITY. A RETINA SPECIALIST WAS AVAILABLE AND INTERVENED DURING THE INITIAL SURGERY; A PARS PLANA VITRECTOMY WAS PERFORMED AND THE FALLEN

  Patient problems: Capsular Bag Tear; Foreign Body In Patient; Iritis; Vitreous Loss

  MAUDE report 20014140 ↗
• InjuryJul 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT WITH A DENSE CATARACT AND WEAK ZONULES UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2024 WHERE THE MILOOP AND MICOR LENS FRAGMENTATION SYSTEM WERE USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS FRAGMENTS. THE MILOOP WAS USED TO SECTION THE LENS INTO 4 QUADRANTS. THE MICOR EXTRACTOR WAS THEN USED TO REMOVE 2 QUADRANTS, AFTER WHICH TIME THE PRESENCE OF ZONULAR DIALYSIS BECAME EVIDENT. THE REMAINING 2 QUARTERS OF THE CATARACTOUS LENS DESCENDED POSTERIORLY THROUGH A POSTERIOR CAPSULAR TEAR AND INTO THE VITREOUS CAVITY. THE EXACT TIMING OF THE ZONULAR/CAPSULAR TEAR IS NOT KNOWN, BUT THE SURGEON STATED THE DAMAGE OCCURRED DURING LENS FRAGMENTATION AND REPORTED A POST-OCCLUSION SURGE DURING MICOR. PATIENT FOLLOW-UP INFORMATION WAS REQUESTED FROM THE SURGEON. ADDITIONAL FOLLOW-UP WAS PROVIDED BY THE SURGEON ON JULY 18, 2024, WHO REPORTS THE PATIENT WAS DOING WELL AND THERE HAS BEEN NO SEQUELAE AND NO ADVERSE IMPACT ON VISION. A RETINA SPECIALIST WAS AVAILABLE AND INTERVENED DURING THE INITIAL SURGERY; A PARS PLANA VITRECTOMY WAS PERFORMED AND THE FALLEN LENS FRAGMENTS WERE REMOVED FROM THE VITREOUS. A DIFFERENT 3-PIECE INTRAOCULAR LENS MODEL WAS IMPLANTED. AT THE PATIE

  Patient problems: Capsular Bag Tear; Foreign Body In Patient; Vitreous Loss

  MAUDE report 19822648 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2024 WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. DURING MICOR USE AT THE END OF NUCLEAR REMOVAL, THE CAPSULAR BAG RUPTURED. THE SURGEON SWITCHED TO ULTRASOUND MACHINE AND PERFORMED AN ANTERIOR VITRECTOMY AND CORTICAL CLEANUP. A SULCUS-FIXATED INTRAOCULAR LENS WAS IMPLANTED AND THE PRIMARY INCISION WAS CLOSED USING 3 INTERRUPTED SUTURES AND 2 PARACENTESES. THE SURGEON ATTRIBUTED THE CAPSULAR DAMAGE TO THE MICOR EXTRACTOR TIP. AT THE ONE-DAY POSTOPERATIVE VISIT THE CORNEA APPEARED MILDLY EDEMATOUS. THE SURGEON DOES NOT ANTICIPATE ANY LONG-TERM SEQUELAE. ADDITIONAL PATIENT FOLLOW-UP WAS PROVIDED BY THE SURGEON ON (B)(6) 2024 WHO REPORTS THE PATIENT IS DOING WELL. AT THE PATIENT'S LAST VISIT ON (B)(6) 2024, THE SUTURES WERE REMOVED AND VISUAL ACUITY IMPROVED COMPARED TO PRIOR VISIT. REFER TO B6 FOR DETAILS. THE PATIENT IS SCHEDULED FOR NEXT FOLLOW-UP ON (B)(6) 2024.

  Patient problems: Capsular Bag Tear; Corneal Edema; Vitreous Loss

  MAUDE report 19492927 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2024, WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. THE CAPSULAR BAG RUPTURED WHILE ATTEMPTING TO REMOVE THE EPINUCLEUS SHELL WITH THE MICOR EXTRACTOR TIP. THE INTRAOCULAR LENS WAS ABLE TO BE IMPLANTED IN THE CAPSULAR BAG AND THERE WAS NO VITREOUS PROLAPSE. THE SURGEON ATTRIBUTED THE CAPSULAR DAMAGE TO THE MICOR EXTRACTOR TIP. AT THE ONE-DAY POSTOPERATIVE VISIT THE CORNEA WAS CLEAR. THE SURGEON DOES NOT ANTICIPATE ANY LONG-TERM SEQUELAE. ADDITIONAL PATIENT FOLLOW-UP WAS PROVIDED BY THE SURGEON ON MAY 30, 2024 WHO REPORTS THE PATIENT IS DOING WELL. AT THE PATIENT'S LAST VISIT ON MAY 30, 2024, IOP IMPROVED AND VISUAL ACUITY REMAINED STABLE. REFER TO B6 FOR DETAILS. THE PATIENT IS SCHEDULED FOR NEXT FOLLOW-UP ON JULY 11, 2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19492233 ↗
• InjuryJun 6, 2024Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2024 WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. THE CAPSULAR BAG RUPTURED DURING CORTICAL REMOVING USING THE MICOR EXTRACTOR. A SULCUS-FIXATED INTRAOCULAR LENS WAS IMPLANTED. THE SURGEON ATTRIBUTED THE CAPSULAR DAMAGE TO THE MICOR EXTRACTOR TIP. AT THE ONE-DAY POSTOPERATIVE VISIT THERE WAS SIGNIFICANT CORNEAL EDEMA. THE PATIENT'S VISUAL POTENTIAL IS UNCLEAR GIVEN MEDICAL HISTORY. ADDITIONAL PATIENT FOLLOW-UP WAS PROVIDED BY THE SURGEON ON MAY 30, 2024 WHO REPORTS THE PATIENT IS DOING WELL. AT THE PATIENT'S LAST VISIT ON MAY 29, 2024, TOPIC STEROIDS WERE BEING TAPERED AND VISUAL ACUITY IMPROVED COMPARED TO PRIOR VISIT; HOWEVER, IOP INCREASED TO 28 MMHG (ON 3 TOPICAL OCULAR HYPOTENSIVE MEDICATIONS). REFER TO B6 FOR DETAILS. THE PATIENT IS SCHEDULED FOR NEXT FOLLOW-UP ON JUNE 3, 2024.

  Patient problems: Capsular Bag Tear; Corneal Edema; Intraocular Pressure Increased

  MAUDE report 19481028 ↗
• InjuryNov 1, 2023Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON OCTOBER 2, 2023 WHERE THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. IRIDODIALYSIS OCCURRED DURING MICOR USE; THE EVENT REQUIRED 6 CLOCK DEGREES OF IRIDODIALYSIS REPAIR. THE SURGEON NOTED THAT THE PATIENT HAD A SMALL PUPIL AND IRIS AND A CAPSULAR TENSION RING WAS PLACED. PREOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IN THE OPERATIVE EYE WAS 20/40 -1, DECREASING TO 20/60 +2 AT THE ONE-WEEK POSTOPERATIVE VISIT. AT THIS VISIT THE PATIENT WAS REPORTED AS HEALING APPROPRIATELY WITH SIGNIFICANT POSTOPERATIVE CORNEAL EDEMA.

  Patient problems: Corneal Edema; Eye Injury

  MAUDE report 18052589 ↗
• InjuryNov 1, 2023Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6), 2023 WHERE THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. DURING MICOR USE, THE PATIENT'S CAPSULAR BAG WAS FLOPPY AND THE HIGH VACUUM SETTING WAS USED; THE MICOR EXTRACTOR CAUGHT THE EQUATOR OF THE CAPSULE WHICH RESULTED IN A SMALL, CIRCULAR POSTERIOR CAPSULAR TEAR. THERE WAS NO VITREOUS LOSS AND A 3-PIECE INTRAOCULAR LENS WAS IMPLANTED WITH OPTIC CAPTURE. PREOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IN THE OPERATIVE EYE WAS 20/40 +2, IMPROVING TO 20/30 AT THE ONE-WEEK POSTOPERATIVE VISIT. AT THIS VISIT THE PATIENT WAS REPORTED AS HEALING APPROPRIATELY AND THERE HAS BEEN NO ADVERSE IMPACT ON VISION AND NO SEQUELAE.

  Patient problems: Capsular Bag Tear

  MAUDE report 18052505 ↗
• InjuryAug 10, 2023Use of Device Problem; Use of Device Problem

  A PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2023 WHERE THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. IMMEDIATELY FOLLOWING LENS EXTRACTION WITH THE MICOR EXTRACTOR THERE WAS ANTERIOR CHAMBER FLUCTUATION (AC SHALLOWING) AND THE POSTERIOR CAPSULE TORE. THERE WAS NO VITREOUS LOSS AND THE PLANNED INTRAOCULAR LENS WAS IMPLANTED. PREOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IN THE OPERATIVE EYE WAS 20/50, IMPROVING TO 20/30 ONE WEEK POSTOPERATIVELY. AT THIS ONE-WEEK POSTOPERATIVE VISIT THE PATIENT WAS REPORTED AS STABLE AND IMPROVING WITH 1+ CORNEAL EDEMA THAT WAS RESOLVING.

  Patient problems: Capsular Bag Tear

  MAUDE report 17505268 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 71-YEAR-OLD FEMALE PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2023 WHERE THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. DURING THE MICOR PROCEDURE THERE WAS ANTERIOR CHAMBER FLUCTUATION AND THE POSTERIOR CAPSULE TORE WHICH RESULTED IN VITREOUS FLUID LOSS. A VITRECTOMY WAS PERFORMED AND A 3-PIECE INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS. PREOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/25. POSTOPERATIVELY, THE PATIENT'S BCVA IMPROVED TO 20/20 AND THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 17329610 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 66-YEAR-OLD MALE PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2023 WHERE THE MILOOP LENS FRAGMENTATION DEVICE WAS USED TO SECTION THE CATARACTOUS LENS INTO 6 FRAGMENTS AND THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS SUBSEQUENTLY USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. WITHIN THE FIRST 10 SECONDS OF INITIATING ASPIRATION WITH THE MICOR EXTRACTOR, THE POSTERIOR CAPSULE TORE AT THE 11 O'CLOCK POSITION. THE TEAR RESULTED IN VITREOUS FLUID LOSS, VITREOUS HEMORRHAGE, AND A PORTION OF THE LENS DROPPED INTO THE VITREOUS CAVITY. AN ANTERIOR VITRECTOMY WAS PERFORMED AND A 3-PIECE INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS. THE SURGEON ATTRIBUTED THE CAPSULAR DAMAGE TO A SURGE EVENT. PATIENT FOLLOW-UP INFORMATION WAS REQUESTED FROM THE SURGEON. AT THE ONE-DAY POSTOPERATIVE VISIT, THE PATIENT PRESENTED WITH 2+ CORNEAL EDEMA, ELEVATED INTRAOCULAR PRESSURE (IOP), AND DECREASED VISUAL ACUITY (20/500). THE PATIENT WAS REFERRED TO A RETINA SPECIALIST AND ON (B)(6) 2023 THE PATIENT UNDERWENT RETINAL SURGERY REMOVE THE RETAINED LENS FRAGMENT(S) AND ADDRESS THE VITREOUS HEMORRHAGE. THE PATIENT'S ONE-WEEK OCULAR STATUS WAS AS FOLLOWS - BEST CORRECTED VISUAL

  Patient problems: Capsular Bag Tear; Foreign Body In Patient; Intraocular Pressure Increased; Loss of Vision; Vitreous Hemorrhage; Vitreous Loss

  MAUDE report 17222230 ↗
• InjuryMay 19, 2023Use of Device Problem; Use of Device Problem

  A 71-YEAR-OLD PATIENT UNDERWENT CATARACT SURGERY ON (B)(6) 2023 WHERE THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS USED TO REMOVE THE CATARACTOUS LENS. THE PATIENT'S POSTERIOR CAPSULE TORE DURING SURGERY. THE TEAR OCCURRED WHILE USING THE MICOR EXTRACTOR DURING REMOVAL OF THE LENS EPINUCLEUS. THERE WAS VITREOUS FLUID LOSS AND THE LENS DROPPED INTO THE VITREOUS CAVITY. AN ANTERIOR VITRECTOMY WAS PERFORMED AND NO INTRAOCULAR LENS WAS IMPLANTED. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST TO ADDRESS THE DROPPED NUCLEUS AND IMPLANT A SULCUS-FIXATED INTRAOCULAR LENS. AT THE ONE-DAY POSTOPERATIVE VISIT, THE PATIENT'S BEST CORRECTED VISUAL ACUITY WAS 20/25. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON WHICH REVEALED THE CAUSE WAS ATTRIBUTED TO SURGICAL TECHNIQUE WHERE AN AGGRESSIVE VERTICAL-CHOP TECHNIQUE WAS EMPLOYED. THERE WERE NO DEVICE PERFORMANCE PROBLEMS WITH THE MICOR SYSTEM.

  Patient problems: Capsular Bag Tear; Foreign Body In Patient; Vitreous Loss

  MAUDE report 16969743 ↗
• InjuryMay 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A (B)(6) PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2022 WHERE THE MILOOP AND MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WERE USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS. THE PATIENT'S POSTERIOR CAPSULE TORE DURING SURGERY. THE TEAR OCCURRED WHILE USING THE MICOR EXTRACTOR DURING REMOVAL OF LENS NUCLEUS WHEN THE REMAINING LENS FRAGMENTS WERE MOVING AROUND IN THE CAPSULAR BAG. THE TEAR RESULTED IN LOSS OF VITREOUS FLUID WHICH REQUIRED AN ANTERIOR VITRECTOMY; A 3-PIECE INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS. THE MICOR EXTRACTOR AND MILOOP DEVICES WERE DISPOSED OF BY THE FACILITY, BUT A VIDEO RECORDING OF THE SURGERY WAS PROVIDED. THE SURGICAL VIDEO REVEALED THE FOLLOWING ADDITIONAL INFORMATION AND INSIGHT. THE PATIENT HAD A GRADE 1+ CATARACT. THE MILOOP WAS USED TO BISECT THE LENS. IT WAS NOTED ON THE FIRST ATTEMPT TO BISECT THAT THE LENS PROLAPSED FORWARD. DURING LENS EXTRACTION USING THE MICOR EXTRACTOR, THE TIP OF THE DEVICE WAS POSITIONED IN CENTER OF THE CORTEX AND THROTTLE INPUT WAS APPROXIMATELY 50% AT THE TIME OF THE POSTERIOR CAPSULAR BAG CAPTURE. THE SURGEON THEN USED THE VACUUM BREAK FEATURE TO RELEASE THE CAPTURED BAG. THERE WAS NO

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 14308163 ↗
• InjuryNov 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  A (B)(6) PATIENT UNDERWENT CATARACT SURGERY ON (B)(6) 2021 WHERE THE MILOOP AND MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WERE USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS. THE PATIENT'S POSTERIOR CAPSULE TORE DURING SURGERY. THE SURGICAL VIDEO REVEALED THE FOLLOWING ADDITIONAL INFORMATION AND INSIGHT. THE MILOOP WAS USED TO BISECT THE PATIENT'S GRADE 3 CATARACTOUS LENS. THERE WERE NO PROBLEMS WITH THE TECHNIQUE USED TO EXECUTE THE MILOOP PROCEDURE. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION WITH THE MILOOP OR MICOR DEVICES. THERE WAS A SMALL RENT IN THE POSTERIOR CAPSULE AT MINUTE 2:57; AT THIS TIME THE MICOR EXTRACTOR WAS IN USE AND THE SPATULA WAS POSITIONED IN THE AREA OF THE TEAR. AT MINUTE 3:06 A LENS FRAGMENT ROTATED WITHIN THE CAPSULE AND AT 3:21 THE TEAR EXPANDED, INCREASING TO A LARGER TEAR BY 3:33. THE SURGEON APPEARED TO PROCEED WITH INTRAOCULAR LENS IMPLANTATION, BUT THIS PORTION OF THE SURGERY WAS NOT RECORDED. THE FINAL CONCLUSION OF THE EXPERT VIDEO ANALYSIS REVEALED NO CLEAR ETIOLOGY. PATIENT FOLLOW-UP HAS BEEN REQUESTED FROM THE SURGEON ON SEVERAL OCCASIONS, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 12848608 ↗
• InjuryNov 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  A (B)(6)-OLD PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2021 WHERE THE MILOOP AND MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WERE USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS. THE PATIENT'S POSTERIOR CAPSULE TORE DURING SURGERY. THERE WAS NO LOSS OF VITREOUS FLUID, NO VITRECTOMY, AND NO CHANGE TO THE INTRAOCULAR LENS IMPLANTED. THE SURGEON REPORTED THE MICOR "FELT RUNNING AT TOO HIGH THROTTLE" AND HE "GOT TOO CLOSE TO THE [CAPSULAR] BAG". THE SURGICAL VIDEO REVEALED THE FOLLOWING ADDITIONAL INFORMATION AND INSIGHT. IT SHOULD BE NOTED THAT THE VIDEO RESOLUTION WAS LOW AND IT WAS NOT POSSIBLE TO IDENTIFY EXACTLY WHEN THE CAPSULAR TEAR OCCURRED. THE PATIENT HAD A DARK IRIS AND A SMALL PUPIL WHICH REQUIRED USE OF AN IRIS RETRACTOR AT THE BEGINNING OF SURGERY. THE MILOOP WAS USED TO BISECT THE PATIENT'S GRADE 3 CATARACTOUS LENS. THERE WERE NO PROBLEMS WITH THE TECHNIQUE USED TO EXECUTE THE MILOOP PROCEDURE. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION WITH THE MILOOP OR MICOR DEVICES AND THERE WAS NO EVIDENCE OF AN OVERSPEED CONDITION. BASED ON THE VIDEO EVIDENCE, IT IS POSSIBLE THAT THE IRIS RETRACTOR AND SURGICAL TECHNIQUE DURING ITS REMOVAL AND/OR BA

  Patient problems: Capsular Bag Tear

  MAUDE report 12844895 ↗