SENSAR IOL AAB00 (REF AAB0000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05050474548657), received between Sep 25, 2017 and Sep 3, 2025 — classified as 5 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING THE NON-PRELOADED INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE IOL WAS UNFOLDING, ONE OF THE HAPTICS WAS BROKEN. THE IOL WAS REMOVED AND REPLACED FROM THE PATIENT'S EYE. A DELAY IN PROCEDURE OCCURRED. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT IS WELL AND THE DELAY IN PROCEDURE WAS NOT SIGNIFICANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959813 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED AS IT WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131611 ↗
• MalfunctionFeb 21, 2024Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN NUMBER OF EVENTS, ON UNKNOWN DATES, OF 'BROWN HAIR' IN PATIENT'S EYES WHEN APPLYING HEALON PRO. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754453 ↗
• MalfunctionFeb 3, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A SENSAR INTRAOCULAR LENS (IOL) HAD THE HAPTIC CUT WHEN THE INJECTOR BEGAN TO DESCEND AND DISPLACE IN THE CARTRIDGE. IT WAS STATED THAT THE IOL ALMOST DID NOT DESCEND, AND IN THE PATIENT'S EYE, THEN THE DOCTOR NOTICED THAT ONLY ONE HAPTIC WENT IN BECAUSE THE OTHER ONE WAS CUT. THE DOCTOR TOOK ANOTHER LENS, AND THIS TIME THE SECOND HAPTIC CAME LOOSE. THE DOCTOR THEN TOOK A NON JOHNSON AND JOHNSON IOL AND THAT ALLOWED HIM TO INJECT THE IOL. THERE WAS NO INCISION ENLARGEMENT , VITRECTOMY, SUTURES DONE ON ANY OF THE 3 SUSPECT LENSES. THIS MDR REPORT PERTAINS TO THE FIRST SUSPECT UNKNOWN EMERALD CARTRIDGE WITH CONCOMITANT AR40E, SERIAL NUMBER (B)(6). THE OTHER SUSPECT PRODUCTS MENTIONED ARE NOT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637144 ↗
• MalfunctionDec 22, 2023Break; Contamination; Break; Contamination

  IT WAS REPORTED THERE WAS AN UNIDENTIFIED SUBSTANCE DURING IMPLANTATION OF THE IOL. THE SURGEON FIRST THOUGHT IT WAS A FOREIGN MATTER AND THOUGHT IT COULD BE A CRACK INSIDE THE IOL, NOT ON THE SURFACE. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384072 ↗
• MalfunctionSep 20, 2023Break; Break

  IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) INJECTOR BENT THE HAPTIC. THE HAPTIC WAS NOTICED TO BE BENT DURING INSERTION OF THE INTRAOCULAR LENS (IOL). THE INCISION WAS ENLARGED TO INSERT THE JNJ LENS. THE IOL WAS FULLY INSERTED AND THEN REMOVED. THE INCISION WAS ENLARGED AGAIN TO INSERT THE ALCON ANTERIOR CHAMBER LENS. THE PROCEDURE WAS COMPLETED WITH THE ALCON LENS (ALCON MTA4UO ANTERIOR CHAMBER LENS). REPORTEDLY, DIRECTIONS FOR USE WERE FOLLOWED AND THE IOL WAS LOADED BY THEIR MOST EXPERIENCED TECHNICIAN. THE DOCTOR DETERMINED THE INJECTOR WAS CAUSING THE HAPTICS TO BEND OUT OF SHAPE. THE DOCTOR SPECIFIED IT'S A JNJ INJECTOR. THERE WAS NO UNPLANNED VITRECTOMY. HOWEVER, SUTURES WERE REQUIRED. NO DELAY IN THE PROCEDURE WAS REPORTED. THE PATIENT HAS FULLY RECOVERED. THE CUSTOMER HAS REMOVED THE INJECTOR FROM THEIR SYSTEM. NO FURTHER INFORMATION WAS REPORTED.

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

  MAUDE report 17778401 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) INJECTOR BENT THE HAPTIC. THE HAPTIC WAS NOTICED TO BE BENT DURING INSERTION OF THE INTRAOCULAR LENS (IOL). THE INCISION WAS ENLARGED TO INSERT THE JNJ LENS. THE IOL WAS FULLY INSERTED AND THEN REMOVED. THE INCISION WAS ENLARGED AGAIN TO INSERT THE ALCON ANTERIOR CHAMBER LENS. THE PROCEDURE WAS COMPLETED WITH THE ALCON LENS (ALCON MTA4U0 ANTERIOR CHAMBER LENS). REPORTEDLY, DIRECTIONS FOR USE WERE FOLLOWED AND THE IOL WAS LOADED BY THEIR MOST EXPERIENCED TECHNICIAN. THE DOCTOR DETERMINED THE INJECTOR WAS CAUSING THE HAPTICS TO BEND OUT OF SHAPE. THE DOCTOR SPECIFIED IT'S A JNJ INJECTOR. THERE WAS NO UNPLANNED VITRECTOMY. HOWEVER, SUTURES WERE REQUIRED. NO DELAY IN THE PROCEDURE WAS REPORTED. THE PATIENT HAS FULLY RECOVERED. THE CUSTOMER HAS REMOVED THE INJECTOR FROM THEIR SYSTEM. NO FURTHER INFORMATION WAS REPORTED.

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

  MAUDE report 17778249 ↗
• MalfunctionJun 22, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR ( IOL) LENS WAS INSERTED BUT WAS REMOVED AND REPLACED BY THE SURGEON USING MICRO INSTRUMENT DURING THE SAME PROCEDURE, AS THE INSERTER DAMAGED THE LENS. THE INCISION WAS ENLARGED, NO SUTURES REQUIRED, A DELAY OF 5 MINUTES WAS REPORTED. THE CUSTOMER HAVE NO FURTHER INFORMATION TO REPORT.

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

  MAUDE report 17186881 ↗
• MalfunctionApr 19, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE AAB00 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) WHEN IOL HAD MISSING SECTION OF THE HAPTIC. THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH A BACK-UP LENS WITH THE SAME MODEL DIOPTER SIZE, AAB00 19.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, NO MEDICAL ATTENTION WAS REQUIRED, AND NO MEDICATION (OUTSIDE OF STANDARD CARE) WAS PRESCRIBED. A DELAY IN THE PROCEDURE WAS REPORTED; HOWEVER, THE LENGTH OF THE DELAY IS UNKNOWN. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY: 20/40 AND POST-OPERATIVE BEST CORRECTED VISUAL ACUITY: 20/25. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773510 ↗
• MalfunctionDec 29, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THE ZCB00 INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. ACCOUNT ALSO MENTIONED POSSIBLE LOADING ERROR. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING POSSIBLE LOADING ERROR STATING WE THINK IT WAS A BENT LENS INSERTER. THE CARTRIDGE HAD PATIENT CONTACT. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS: GOOD. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. ADDITIONAL INFORMATION WAS ACQUIRED THROUGH FOLLOW-UP CONFIRMING THE LENS INSERTER WAS BENT AND THE INSTRUMENT WAS REPAIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075096 ↗
• MalfunctionDec 29, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A LABELING UPDATE AND REVIEW BY TRANSLATION AGENCY, THE FOLLOWING ERROR WAS FOUND IN THE LABEL OF SOME CONSUMER EYE HEALTH (CEH) PRODUCTS. IN FRENCH THERE IS AN INCORRECT TRANSLATION AS PER SOURCE TEXT. INSTEAD OF "DO NOT RINSE OR STORE YOUR LENSES/LENS CASE WITH TAP WATER", YOU CAN FIND ¿DO NOT RINSE THE LENSES OR THEIR CASE WITH TAP WATER¿, HENCE THE WORD ¿STORE¿ IS MISSING. FOUR STOCK KEEPING UNITS (SKU) ARE AFFECTED: 1. 94323QA ACUVUE REVITALENS MPDS SC 60ML+LC SAMPLE ¿ CARTON AM61491QA10E AND INSERT AM70574QA11J (SHARED WITH 94324QA, 94326QA) AFFECTED IN FR. 2. 94324QA ACUVUE REVITALENS MPDS SC 100ML+LC ¿ CARTON AM61492QA10E AFFECTED IN FR . 3. 94326QA ACUVUE REVITALENS MPDS SC 360ML+LC ¿ CARTON AM61494QA10E AFFECTED IN FR. 4. 94327RH ACUVUE REVITALENS MPDS SC 2X300ML+2LC ¿ CARTON AM61495RH10E AND INSERT. AM70574RH11J AFFECTED IN FR. THROUGH FOLLOW-UP WE LEARNED THAT THE INSERT AM70574FM11J CONTAINS THE ERROR AS WELL. PRODUCTS ARE NOT AVAILABLE AS THE ISSUE WAS IDENTIFIED DURING LABELING REVIEW AND NO INDIVIDUAL PRODUCTS ARE INVOLVED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS BEING SUBMITTED FOR ACUVUE REVITALENS WITH SKU/CATALOG NUMBER 94

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074363 ↗
• MalfunctionDec 29, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A LABELING UPDATE AND REVIEW BY TRANSLATION AGENCY, THE FOLLOWING ERROR WAS FOUND IN THE LABEL OF SOME CONSUMER EYE HEALTH (CEH) PRODUCTS. IN FRENCH THERE IS AN INCORRECT TRANSLATION AS PER SOURCE TEXT. INSTEAD OF "DO NOT RINSE OR STORE YOUR LENSES/LENS CASE WITH TAP WATER", YOU CAN FIND ¿DO NOT RINSE THE LENSES OR THEIR CASE WITH TAP WATER¿, HENCE THE WORD ¿STORE¿ IS MISSING. FOUR STOCK KEEPING UNITS (SKU) ARE AFFECTED: 1. 94323QA ACUVUE REVITALENS MPDS SC 60ML+LC SAMPLE ¿ CARTON AM61491QA10E AND INSERT AM70574QA11J (SHARED WITH 94324QA, 94326QA) AFFECTED IN FR. 2. 94324QA ACUVUE REVITALENS MPDS SC 100ML+LC ¿ CARTON AM61492QA10E AFFECTED IN FR . 3. 94326QA ACUVUE REVITALENS MPDS SC 360ML+LC ¿ CARTON AM61494QA10E AFFECTED IN FR. 4. 94327RH ACUVUE REVITALENS MPDS SC 2X300ML+2LC ¿ CARTON AM61495RH10E AND INSERT AM70574RH11J AFFECTED IN FR. THROUGH FOLLOW-UP WE LEARNED THAT THE INSERT AM70574FM11J CONTAINS THE ERROR AS WELL. PRODUCTS ARE NOT AVAILABLE AS THE ISSUE WAS IDENTIFIED DURING LABELING REVIEW AND NO INDIVIDUAL PRODUCTS ARE INVOLVED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS BEING SUBMITTED FOR ACUVUE REVITALENS WITH SKU/CATALOG NUMBER 943

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074276 ↗
• MalfunctionDec 29, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A LABELING UPDATE AND REVIEW BY TRANSLATION AGENCY, THE FOLLOWING ERROR WAS FOUND IN THE LABEL OF SOME CONSUMER EYE HEALTH (CEH) PRODUCTS. IN FRENCH THERE IS AN INCORRECT TRANSLATION AS PER SOURCE TEXT. INSTEAD OF "DO NOT RINSE OR STORE YOUR LENSES/LENS CASE WITH TAP WATER", YOU CAN FIND ¿DO NOT RINSE THE LENSES OR THEIR CASE WITH TAP WATER¿, HENCE THE WORD ¿STORE¿ IS MISSING. FOUR STOCK KEEPING UNITS (SKU) ARE AFFECTED: 1. 94323QA ACUVUE REVITALENS MPDS SC 60ML+LC SAMPLE ¿ CARTON AM61491QA10E AND INSERT AM70574QA11J (SHARED WITH 94324QA, 94326QA) AFFECTED IN FR. 2. 94324QA ACUVUE REVITALENS MPDS SC 100ML+LC ¿ CARTON AM61492QA10E AFFECTED IN FR. 3. 94326QA ACUVUE REVITALENS MPDS SC 360ML+LC ¿ CARTON AM61494QA10E AFFECTED IN FR. 4. 94327RH ACUVUE REVITALENS MPDS SC 2X300ML+2LC ¿ CARTON AM61495RH10E AND INSERT AM70574RH11J AFFECTED IN FR. THROUGH FOLLOW-UP WE LEARNED THAT THE INSERT AM70574FM11J CONTAINS THE ERROR AS WELL. PRODUCTS ARE NOT AVAILABLE AS THE ISSUE WAS IDENTIFIED DURING LABELING REVIEW AND NO INDIVIDUAL PRODUCTS ARE INVOLVED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS BEING SUBMITTED FOR ACUVUE REVITALENS WITH SKU/CATALOG NUMBER 9432

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074219 ↗
• MalfunctionDec 29, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A LABELING UPDATE AND REVIEW BY TRANSLATION AGENCY, THE FOLLOWING ERROR WAS FOUND IN THE LABEL OF SOME CONSUMER EYE HEALTH (CEH) PRODUCTS. IN FRENCH THERE IS AN INCORRECT TRANSLATION AS PER SOURCE TEXT. INSTEAD OF "DO NOT RINSE OR STORE YOUR LENSES/LENS CASE WITH TAP WATER", YOU CAN FIND ¿DO NOT RINSE THE LENSES OR THEIR CASE WITH TAP WATER¿, HENCE THE WORD ¿STORE¿ IS MISSING. FOUR STOCK KEEPING UNITS (SKU) ARE AFFECTED: 1. 94323QA ACUVUE REVITALENS MPDS SC 60ML+LC SAMPLE ¿ CARTON AM61491QA10E AND INSERT AM70574QA11J (SHARED WITH 94324QA, 94326QA) AFFECTED IN FR. 2. 94324QA ACUVUE REVITALENS MPDS SC 100ML+LC ¿ CARTON AM61492QA10E AFFECTED IN FR . 3. 94326QA ACUVUE REVITALENS MPDS SC 360ML+LC ¿ CARTON AM61494QA10E AFFECTED IN FR. 4. 94327RH ACUVUE REVITALENS MPDS SC 2X300ML+2LC ¿ CARTON AM61495RH10E AND INSERT AM70574RH11J AFFECTED IN FR. THROUGH FOLLOW-UP WE LEARNED THAT THE INSERT AM70574FM11J CONTAINS THE ERROR AS WELL. PRODUCTS ARE NOT AVAILABLE AS THE ISSUE WAS IDENTIFIED DURING LABELING REVIEW AND NO INDIVIDUAL PRODUCTS ARE INVOLVED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS BEING SUBMITTED FOR ACUVUE REVITALENS WITH SKU/CATALOG NUMBER 943

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074192 ↗
• MalfunctionDec 23, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A RED DOT SIZED MARK ON THE LENS. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16045702 ↗
• MalfunctionDec 22, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS VERY HARD TO TURN AND THE LENS LOOKED DEFECTIVE. THE SURGEON HAD TO USE A BACK-UP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036873 ↗
• MalfunctionSep 1, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BENT AND WOULD NOT EJECT FROM THE CARTRIDGE. ALTHOUGH, THE REPORT NOTED THERE WAS NO PATIENT CONTACT; IT ALSO INDICATED THAT THE EVENT WAS OBSERVED DURING IMPLANTATION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR NO SUTURES REQUIRED. THERE WAS NO DELAY IN PROCEDURE REPORTED. THE DAILY ACTIVITIES WAS NOT SIGNIFICANTLY AFFECTED AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411804 ↗
• MalfunctionMar 19, 2021Break; Break

  IT WAS REPORTED THAT HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS BENT DURING LOADING. THERE WAS PATIENT CONTACT. HOWEVER, THERE WAS NO INJURY AND THE PROCEDURE WAS COMPLETED USING SAME TYPE OF LENS. THE DAMAGED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11532692 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THE PATIENT NOTED SYMPTOMS IN (B)(6) 2020 POST-IMPLANT. THERE WAS NO PATIENT INJURY, AND THE PATIENT IS DOING FINE POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10865560 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AAB00 19.5 DIOPTER, INTRAOCULAR LENS (IOL) WAS INSERTED. HOWEVER A VITRECTOMY WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS WAS REMOVED FROM THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vitrectomy

  MAUDE report 9808760 ↗
• MalfunctionJan 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN AAB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) CRACKED UPON INSERTION INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THE LENS REMAINS IMPLANTED AND THE REMNANTS OF THE CRACKED INTRAOCULAR LENS WERE REMOVED DURING THE IRRIGATION/ASPIRATION (I/A) PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8230655 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, THE PATIENT'S POSTERIOR CAPSULE WAS RUPTURED. REPORTEDLY, THE INTRAOCULAR LENS (MODEL AAB00 +19.5 DIOPTER) WAS NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7949651 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (MODEL AAB00 +19.5 DIOPTER) BREAKAGE OF THE EDGE OF THE PATIENT'S ANTERIOR CAPSULAR BAG WAS NOTICED. REPORTEDLY, A 3-PIECE LENS WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7948595 ↗
• MalfunctionJun 28, 2018Break; Sticking; Break; Sticking

  IT WAS REPORTED THAT DURING THE INSERTION INTO THE PATIENT''S OPERATIVE EYE OF THE AAB00 INTRAOCULAR LENS (IOL), THE HAPTIC WAS STUCK TO THE OPTIC. REPORTEDLY, THE HAPTIC COULD NOT BE RELEASED AND THE LENS GOT DAMAGED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7644821 ↗
• InjurySep 25, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL AAB00, +19.5 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE RIGHT EYE OF A MALE PATIENT BECAUSE OF A POST-OPERATIVE REFRACTIVE ERROR. REPORTEDLY ANOTHER LENS, SAME MODEL HIGHER DIOPTER (+21.0) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6889445 ↗