WHITESTAR SIGNATURE OPO73Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 15050474602080), received between Aug 29, 2017 and Jun 10, 2026 — classified as 27 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Dec 7, 2022Class IIOpen, Classified

   Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

   Z-1006-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT PPG ST MARY¿S PORTSMOUTH HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO THE COMPANY¿S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, STEROIDS AND TOPICAL ANTIBIOTICS ONLY (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 25453293 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT (B)(6) HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO THE COMPANY¿S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP WE LEARNED THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, PHACO HANDPIECE, TUBING SETS AND (B)(6) WERE USED ON EACH PATIENT. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL REMAIN CODED WITH TOPICAL STEROIDS. AS WE CANNOT IDENTIFY THE PHACO HANDPIECE USED IN CONJUNCTION WITH THIS SPECIFIC IOL, THEY A

  Patient problems: Endophthalmitis

  MAUDE report 25453246 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT PPG ST MARY¿S PORTSMOUTH HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO THE COMPANY¿S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, STEROIDS AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. NO FURTHER INFORMATION HAS

  Patient problems: Endophthalmitis

  MAUDE report 25453181 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT (B)(6) HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO THE COMPANY¿S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP WE LEARNED THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, PACHO HANDPIECE, TUBING SETS AND (B)(6) WERE USED ON EACH PATIENT. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL REMAIN CODED WITH TOPICAL STEROIDS. AS WE CANNOT IDENTIFY THE PHACO HANDPIECE USED IN CONJUNCTION WITH THIS SPECIFIC IOL, THEY A

  Patient problems: Endophthalmitis

  MAUDE report 25453171 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THE TIME IT WAS NOT KNOWN WHETHER THE INFECTION WAS RELATED TO J&J PRODUCTS, BUT THE HOSPITAL NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, STEROIDS AND TOPICAL ANTIBIOTICS ONLY. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 25453086 ↗
• MalfunctionJun 5, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING PROCEDURE WHEN USING THE PHACO TUBING PACK AND THE HANDPIECE, A FOREIGN MATERIAL CAME OUT FROM THE TIP. IT WAS ASPIRATED FROM THE PATIENT'S EYE AND THE PHACO TUBING PACK WAS REPLACED. NO INFLAMMATION WAS OBSERVED IN THE PATIENTS EYE AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED. NOTE: A SEPARATE REPORT WILL BE SUBMITTED FOR THE HANDPIECE AND THE HANDPIECE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151009 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT HAD A CORNEAL BURN DURING SCULPT AND REQUIRED 4 SUTURES TO CLOSE THE WOUND. THERE WAS NO POST-OPERATIVE COMPLICATION AND NO PERMANENT DAMAGE TO CORNEA/SCLERA. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE OPO73. SEPARATE REPORTS WILL BE SUBMITTED AGAINST THE VERITAS CONSOLE, ELLIPS HANDPIECE AND 21G TIP.

  Patient problems: Eye Burn

  MAUDE report 21939557 ↗
• InjuryMar 20, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, USING THE WHITESTAR SIGNATURE PRO SYSTEM, A CHALLENGING CASE INVOLVING A PATIENT WITH GLAUCOMA WAS ENCOUNTERED. THE SURGEON FACED DIFFICULTIES DUE TO THE PATIENT'S PUPIL NOT DILATING AND A SHALLOW CHAMBER. DESPITE CONSIDERING STOPPING THE PROCEDURE, HE DECIDED TO CONTINUE, WHICH LED TO COMPLICATIONS WITH A FLOPPY IRIS THAT PROLAPSED THROUGH THE CORNEAL INCISION. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. AN UNPLANNED VITRECTOMY WAS PERFORMED, AND THE VITRECTOMY CUTTER FUNCTIONED AS EXPECTED. HOWEVER, THE SURGEON WAS UNABLE TO IMPLANT THE INTRAOCULAR LENS (IOL) AND OPTED TO RECALL THE PATIENT FOR A FUTURE PROCEDURE USING A THREE-PIECE IOL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury

  MAUDE report 21657894 ↗
• InjuryMar 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON MENTIONED THERE WERE BUBBLES VISIBLE DURING THE PROCEDURE. HE EXPERIENCED A VITRECTOMY AND ADDED THAT HE THOUGHT THE BUBBLES WERE THE CAUSE. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. WE LEARNED THROUGH FOLLOW UP THE BUBBLES WERE SEEN DURING THE PROCEDURE, DURING CHOP, THE QUADRANT AND IRRIGATION/ASPIRATION PHASE. IT IS UNKNOWN HOW THE PATIENT IS NOW. THROUGH FURTHER FOLLOW UP IT WAS CONFIRMED THE SUSPECT DEVICE WAS OPO73, LOT NUMBER NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520034 ↗
• InjuryJul 3, 2024Failure to Prime; Suction Problem; Failure to Prime; Suction Problem

  IT WAS REPORTED THAT WHEN USING THE OPO73 UNIT, A PRIME ISSUE (ERROR 501) OCCURRED SEVERAL TIMES. THE PACK WAS RESEATED SEVERAL TIMES AND PRIMING WAS PERFORMED. THERE WAS NO SUCTION AND WHEN IT SUDDENLY STARTED, IT DAMAGED THE PATIENT'S CAPSULE. THE PHYSICIAN USED A A-VIT DEVICE INTENDED TO TREAT THE CAPSULE RUPTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19666729 ↗
• InjuryMay 16, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A CORNEAL BURN OCCURRED DURING SCULPT MODE AFTER DOCTOR REALIZED SHE HAD BEEN PERFORMING PHACO WITH THE OPO73 AS THE IRRIGATION LINE HAD DISCONNECTED FROM HER ELLIPSFX ULTRASOUND HAND PIECE. LINE WAS RECONNECTED AND CASE COULD BE COMPLETED. HOWEVER, SUTURES HAD TO BE MADE TO CLOSE THE IMPACTED MAIN INCISION TO ASSURE PROPER WOUND SEALING AT END OF THE PROCEDURE. POST OP DAY 1 SHOWED 20/100 VISUAL ACUITY (VA) BUT ON FOLLOW UP, DOCTOR STATED THAT THIS IS PROBABLY SECONDARY TO PATIENT'S TIGHT SUTURES AS CORNEAL EDEMA ON THIS LEFT EYE WAS VERY LIGHT, SHE ADDED, NOT LIKELY TO IMPACT VA. SIGNATURE PRO, OPO73 AND OPOCR3021L WITH ALCON BALANCED SALT SOLUTION (BSS) HAD BEEN USED ALL DAY WITHOUT ISSUE. DOCTOR IS VERY EXPERIENCED WITH THIS SYSTEM AND UNDER THESE PROGRAM SETTINGS. DOCTOR RELATES ISSUE ON IRRIGATION LINE BEING DISCONNECTED FOR A WHILE, NOT COOLING DOWN HER PHACO TIP. DENIED HAVING SYSTEM OR HAND PIECE CHECKED ON THIS MATTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Eye Burn

  MAUDE report 19327801 ↗
• InjuryMar 20, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THERE WAS A CLOGGING ISSUE WITH OPO73 TUBING AND AS A RESULT A CORNEAL BURN OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 18947206 ↗
• InjuryJan 23, 2024Reflux within Device; Suction Problem; Reflux within Device; Suction Problem

  IT WAS REPORTED THAT THE HANDPIECE GOT DETACHED FROM THE TUBING UNIT DURING PHACOEMULSIFICATION PROCEDURE, RESULTING IN INSUFFICIENT REFLUX AND THE IRIS BEING ACCIDENTALLY BEING ASPIRATED. IT BECAME DIFFICULT TO PERFORM THE SURGERY, AND ALTHOUGH THE CRYSTALLINE LENS WAS CLEANED, AN INTRAOCULAR LENS (IOL) COULD NOT BE IMPLANTED, SO AN IOL WILL BE IMPLANTED AT A LATER DATE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18567578 ↗
• InjuryDec 27, 2023Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A CASE OF SUDDEN POSTERIOR VESICLE DAMAGE WHICH OCCURRED DURING IRRIGATION/ASPIRATION (IA) STEP FOR REMOVAL OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) ON THE PATIENT'S RIGHT EYE. THE DOCTOR THINKS THERE IS A POSSIBILITY THAT THERE IS A PROBLEM WITH THE SUCTION OF IA DUE TO THE IA TIP. THE PHYSICIAN HAS BEEN USING SIGPRO FOR MORE THAN THREE YEARS, BUT THIS IS THE FIRST TIME TO HAVE THESE ISSUES. THROUGH FOLLOW-UP WE LEARNED, THAT AN ISTENT WAS USED AND POSTERIOR CAPSULE DAMAGE DURING OVD REMOVAL AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. THE IOL IMPLANTED WAS A DFW375 SERIAL NUMBER: (B)(6) DUE TO PATIENT INJURY THIS LENS WAS EXPLANTED, AND THE FOLLOWING LENS WAS IMPLANTED: AR40E 21.5D SERIAL NUMBER: (B)(6). DIAMOX WAS PRESCRIBED DUE TO INCREASED INTRAOCULAR PRESSURE. A VITRECTOMY WAS PERFORMED AND THE INCISION TO THE EYE WAS ENLARGED, REQUIRING SUTURES. THE OPERATION ON THE PATIENT'S LEFT EYE WAS POSTPONED. NO OTHER COMPLICATIONS WERE REPORTED AND HEALON NA 0.85 WAS USED FOR THESE CASE WITHOUT ISSUES RELATED TO IT. NO FURTHER DETAILS WERE PROVIDED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER JNJ DEVICE INVOLVED FOR THIS PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Intraocular Pressure Increased

  MAUDE report 18400936 ↗
• MalfunctionMay 11, 2023Contamination; Use of Device Problem; Contamination; Use of Device Problem

  IT WAS REPORTED THAT FOREIGN MATTER, WHICH LOOKED LIKE A PIECE OF SOFT PLASTIC (WAS TRANSPARENT BUT WAS TANGIBLE), WAS FOUND IN THE PATIENT'S EYE. IT WAS SAID THIS WAS THE THIRD PROCEDURE OF THE DAY. THE DOCTOR EXTRACTED THE FOREIGN MATTER FROM THE PATIENT'S EYE PRIOR THE IOL IMPLANTATION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. IT WAS ALSO REPORTED THAT, IFU (INSTRUCTION FOR USE) WAS NOT FOLLOWED AS THE SINGLE USE OPO73 PHACO TUBING THAT WAS USED HAD BEEN USED IN MULTIPLE PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914362 ↗
• MalfunctionApr 10, 2023Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PHACO TUBING PACK HAD A CRACK IN PLASTIC CARTON. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709420 ↗
• InjuryApr 5, 2023Use of Device Problem; Suction Problem; Use of Device Problem; Suction Problem

  IT WAS REPORTED THAT CUSTOMER FOUND NUCLEAR FRAGMENTS REMAINED IN THE ANTERIOR CHAMBER DURING THE POST EXAMS. SURGEON PERCEIVED THAT THE VACUUM PERFORMANCE DURING IRRIGATION ASPIRATION AND PHACO MODE WAS BIT LOW. THE ISSUE HAD OCCURRED IN THREE PROCEDURES SINCE AFTER THE MACHINE WAS CHECKED ON 2/7/2023. REPORTEDLY TRANSCONJUNCTIVAL SINGLE PLANE SCLERCORNEAL INCISION METHOD WAS USED WITH 2.55 MM INCISION SIZE. THERE WAS NO INCISION WIDENED. IRRIGATION, SUCTION, AND REMOVAL WITH IRRIGATION ASPIRATION IS PLANNED FOR END OF (B)(6) 2023. PATIENT WAS PRESCRIBED WITH MEDICATION (LEVOFLOXACIN, SANBETASON). THE PATIENT OUTCOME WAS REPORTED AS GOOD VISUAL ACUITY WITH NO PROBLEMS. THE PACK WAS REUSED FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT ON (B)(6) 2023 THERE WAS REMOVAL OF RESIDUAL NUCLEAR FRAGMENTS PERFORMED USING OPHTHALMIC ANESTHESIA. SURGEON ASPIRATED BY USING A BI-MANUAL IRRIGATION ASPIRATION (IA) WHILE SHATTERING NUCLEAR FRAGMENTS WITH THE TIP. NUCLEAR FRAGMENTS WERE ASPIRATED WITHOUT PROBLEMS. THERE WAS DESCEMET'S FOLD THAT SEEMED TO BE CAUSED BY AN EFFECT OF THE BI-MANUAL IA OPERATION. AS A RESULT, VISUAL ACUITY DECREASED FROM 0.9 TO 0.6, BUT ACC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Abrasion

  MAUDE report 16687006 ↗
• InjuryJan 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING A CASE DOCTOR PERFORMED A VITRECTOMY AND HE ATTRIBUTED IT TO THE POST OCCLUSION SURGE USING OPO73 TUBING PACKS WITH LOT NUMBER 60399685 IN CONJUNCTION WITH THE VERITAS SN (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE OPO73. REFER TO 3012236936-2023-00113 FOR THE REPORT OF THE VERITAS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159864 ↗
• MalfunctionSep 26, 2022Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS A THORN ON THE BLUE CONNECTOR OF IRRIGATION TUBE OF OPO73, AND A NURSE WAS HURT WITH THE THORN. THE THORN PENETRATED SURGICAL GLOVE AND PRICKED HER SKIN FOR LESS THAN 1MM. IT WAS NOT A SERIOUS INJURY, AND SHE IS RECOVERING. CUSTOMER USED THE OPO73 FOR A PROCEDURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CUSTOMER DISCARDED THE OPO73 BECAUSE THE PRODUCT WAS USED FOR A PATIENT WHO HAD CONTAGIOUS DISEASE. PATIENT WAS NOT INJURED. ALTHOUGH, THE PRODUCT WAS DISCARDED; THE THORN WAS COLLECTED FOR INVESTIGATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15487126 ↗
• InjurySep 20, 2022Complete Blockage; Failure to Prime; Suction Problem; Complete Blockage; Failure to Prime; Suction Problem

  IT WAS REPORTED EQUIPMENT PRESENTED PRIME EXCESSIVE VACUUM ERROR 501 DURING THE FOURTH PATIENT PROCEDURE WITH THE SAME KIT ON A PATIENTS LEFT (OS) EYE. CUSTOMER INFORMED THAT PERFORMED THE EXCHANGE OF THE TUBING PACK, PERFORMED THE PRIME/TUNE AND WHEN RESUMING THE PROCEDURE, THE ERROR REPEATED AND DURING THE ATTEMPTS, THE INCISION BURNED. CUSTOMER INFORMED THAT THE SURGERY HAD TO BE COMPLETED ON THE BACKUP EQUIPMENT AND LENS WAS IMPLANTED IN THE CAPSULAR BAG. PRIME/TUNE TEST PERFORMED WITH THE 2 KITS USED BY THE CUSTOMER WHERE ERROR 501 WAS CONFIRMED.

  Patient problems: Eye Burn

  MAUDE report 15457746 ↗
• InjuryAug 25, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT FELT HEAT WHILE SURGEON WAS SCULPTING A GROOVE IN A NUCLEUS WITH ELLIPS FX HANDPIECE. SURGEON IMMEDIATELY TOOK THE TIP OFF FROM THE PATIENT'S EYE. THE INCISION IN PATIENT'S EYE RECEIVED MILD THERMAL BURN. THE SURGEON CHECKED THE HANDPIECE AND CONFIRMED THE HANDPIECE HAD BECOME HOT. SURGEON REPLACED WITH THE PHACO MACHINE AND EQUIPMENT OF ANOTHER COMPANY¿S PRODUCT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. SURGEON USED THE US POWER 85% SETTING AND FULLY APPLIED THE FOOT PEDAL WHEN THE ISSUE OCCURRED. OPO73 FUSION DUAL PUMP PACK WAS USED FOR MULTIPLE PROCEDURES PRIOR TO THE INCIDENT. OPO73 WAS DISCARDED BY THE CUSTOMER AND NO SAMPLE WAS GOING TO BE RETURNED FOR INVESTIGATION. THERE WAS NO VITRECTOMY PERFORMED, NO MEDICATION FOR THERMAL BURN TREATMENT WAS REPORTEDLY PROVIDED. SUTURES WERE USED TO PREVENT FURTHER PATIENT INJURY. THE INCISION SIZE WAS REPORTED AS 2.4MM. THIS REPORT IS FOR OPO73 FUSION DUAL PUMP PACK. A SEPARATE MDR REPORT IS BEING SUBMITTED FOR ELLIPS FX PHACO HANDPIECE SYSTEM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 15299258 ↗
• MalfunctionMar 11, 2022Contamination; Contamination

  IT WAS REPORTED THAT A FOREIGN MATTER, WHICH LOOKED LIKE A PIECE OF METAL 2-3MM LONG, ENTERED INTO PATIENT¿S EYE AT THE BEGINNING OF PHACO PROCEDURE DURING SURGERY. THE FOREIGN MATTER WAS IMMEDIATELY REMOVED FROM PATIENT¿S EYE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13728450 ↗
• MalfunctionOct 30, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHITE FOREIGN MATERIAL CAME OUT FROM THE GAP BETWEEN THE PHACO TIP AND THE SLEEVE AND ENTERED IN THE PATIENTS EYE DURING A CATARACT PROCEDURE. THE FOREIGN MATERIAL WAS REMOVED FROM THE EYE WITH FORCEPS AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724904 ↗
• InjuryAug 26, 2021Suction Problem; Suction Problem

  THE ACCOUNT REPORTED THAT THEY EXPERIENCE POOR ASPIRATION DURING PROCEDURE. THE POSTERIOR CAPSULE RUPTURE OCCURRED IN PATIENT'S LEFT OPERATIVE EYE. AN ANTERIOR VITRECTOMY WAS DONE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 3 MINUTES DELAY.

  Patient problems: Capsular Bag Tear

  MAUDE report 12375450 ↗
• MalfunctionJan 13, 2021Break; Delivered as Unsterile Product; Break; Delivered as Unsterile Product

  A STERILITY ASSURANCE CONCERN WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT THERE WAS DAMAGE TO THE OPO73 PHACO TUBING PACK TRAY AND THEY WERE UNSURE IF THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168071 ↗