SENSAR IOL AAB00 (REF AAB0000205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474548671), received between Aug 29, 2016 and Apr 22, 2025 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE STANDALONE MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THAT ONE HAPTIC WAS SLIGHTLY DAMAGED. CONSEQUENTLY, HE DECIDED TO REMOVE THE LENS AND IMPLANT ANOTHER ONE. THE INCISION WAS ENLARGED, AND SUTURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS RECEIVED.

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

  MAUDE report 21886375 ↗
• MalfunctionAug 22, 2024Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT WHEN IMPLANTING THE NON-PRELOADED INTRAOCULAR LENS (IOL), IT WAS SEEN THAT THE HAPTIC BROKE DURING ASSEMBLY INSIDE THE CARTRIDGE. ANOTHER LENS WAS OPENED. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE HAPTIC WAS COMPLETELY DISCONNECTED. THE ISSUE WAS DUE TO LOADING/ASSEMBLY ERROR; WHEN ASSEMBLING, THE INJECTOR TOUCHED THE HAPTIC, NEXT TO THE LENS OPTICS. WHEN INSERTING, THE LENS ONLY WENT IN WITH THE FIRST HAPTIC. THE LENS WAS INSERTED IN THE RIGHT EYE. WHEN THE SURGEON NOTICED IT WAS MISSING ITS HAPTIC, IT WAS TAKEN OUT AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. THERE WAS NO INDICATION OF ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040407 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS CHANGED. IT WAS INDICATED THAT THERE WAS PATIENT CONTACT. THE PRODUCT IS NOT BEING RETURNED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE LENS WAS REMOVED ON THE SAME DAY OF INSERTION AND NOT DURING A SECONDARY SURGICAL PROCEDURE. IT WAS INDICATED THAT THERE WAS NO ISSUE WITH THE LENS OTHERWISE THE DOCTOR WOULD HAVE WRITTEN THAT DOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686607 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO A PATIENT¿S LEFT EYE, VITREOUS WAS SEEN. WHEN CATARACT WAS FULLY REMOVED, THE CAPSULAR BAG WAS INTACT. THE LENS WAS IMPLANTED INTO THE CAPSULAR BAG AND AFTER HAPTICS FULLY OPENED, VITREOUS WAS PRESENT AT THE MAIN INCISION SITE. THE LENS WAS CUT AND REMOVED, AND A NON-JOHNSON & JOHNSON 3-PIECE SULCUS LENS OF THE SAME DIOPTER WAS IMPLANTED. THE INCISION WAS ENLARGED, AND SUTURE USED. THE ACCOUNT INDICATED THAT THEY DO NOT KNOW IF THE REASON FOR THE VITREOUS AT THE INCISION SITE WAS DUE TO THE LENS OR ANY OTHER MEANS. REPORTEDLY, THE PATIENT IS DOING WELL POST-OPERATIVELY AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16259831 ↗
• MalfunctionOct 18, 2021Material Opacification; Material Opacification

  IT WAS REPORTED THAT PATIENT HAS VISUAL DISTURBANCE FROM LAST 6 MONTHS AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. HOWEVER, DUE TO COVID-19, HE DELAYED HIS VISIT TO HOSPITAL. UPON FURTHER FOLLOW-UP DURING REVIEW, SURGEON IDENTIFIED THAT IOL HAS OPACITY. PATIENT VISION IS CURRENTLY IMPAIRED AND DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. NO SURGICAL INTERVENTION PERFORMED YET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 12651143 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS CHANGED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE LENS WAS EXPLANTED FROM PATIENT'S EYE AND A 3-PIECE LENS WAS CHOSEN. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891878 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT A AAB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT'S OPERATIVE EYE DUE TO BROKEN HAPTIC. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. PATIENT WAS DOING STABLE AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587311 ↗
• MalfunctionJan 9, 2021Break; Material Fragmentation; Use of Device Problem; Break; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT THE TECHNICIAN HAD LOADING ISSUE WITH THE SENSAR INTRAOCULAR LENS (IOL). UPON INSERTION, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS TORN OFF. LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS WITHOUT FURTHER INCIDENT. PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143984 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL AAB00 INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF REFRACTIVE ERROR. THE PATIENT WAS DOING FINE AT THE TIME OF DISCHARGE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AN INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE LENS FROM PATIENT'S EYE. THERE WERE NO SUTURES OR VITRECTOMY REQUIRED. THERE WAS NO ISSUE WITH THE LENS AND NO PATIENT INJURY. THE PATIENT DOES NOT HAVE ANY PRE-EXISTING MEDICAL CONDITIONS RELATED TO THE EYE. THE REPLACEMENT LENS IS A SAME MODEL BUT LOWER DIOPTER, 18.5. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10865197 ↗
• MalfunctionMar 25, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS NOTICED SCRATCHED AFTER IT WAS INSERTED INTO THE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH A LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8447051 ↗
• InjuryFeb 20, 2019Contamination; Contamination

  IT WAS REPORTED THAT AN AAB00 20.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO FIBER BEING FOUND ON THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8352865 ↗
• MalfunctionJan 3, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT AN AAB00 20.5 DIOPTER INTRAOCULAR LENS (IOL) HAD A CLOUDY WHITE SPOT ON IT THAT WAS NOTICED DURING HANDLING AND PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT, NO PATIENT INJURY, AND THE LENS WAS OPENED AND NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8211393 ↗
• MalfunctionJun 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A RING ON IT. THIS WAS NOTICED DURING PREPARATION, SO THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Patient Involvement

  MAUDE report 7624563 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (MODEL AAB00, +20.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE. THE LENS WAS SWITCHED TO SPECIALTY TELESCOPIC LENS FOR PATIENT'S MACULAR DEGENERATION. REPORTEDLY, DURING THE PROCEDURE THE INCISION WAS ENLARGED AND SUTURES WERE PLACED. THE PATIENT WAS REPORTED TO BE DOING WELL WHEN DISCHARGED. THERE WAS NO PATIENT INJURY, AND NO OTHER SURGICAL OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7389585 ↗
• MalfunctionFeb 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEBRIS WAS NOTICED ON A AAB00 20.5 DIOPTER INTRAOCULAR LENS (IOL) AFTER IT WAS PLACED IN THE PATIENT'S CAPSULAR BAG. THE DOCTOR REMOVED THE DEBRIS PRIOR TO COMPLETING THE SURGERY AND THE LENS REMAINS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7279014 ↗
• InjuryDec 14, 2017Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC BROKE OFF OF A AABOO 20.5 DIOPTER INTRAOCULAR LENS (IOL) WHEN THE DOCTOR WAS IMPLANTING THE LENS INTO THE PATIENT'S LEFT EYE (OS). THEREFORE, THE DOCTOR ENLARGED THE INCISION WHEN INSERTING THE NEW, REPLACEMENT LENS. THE REPLACEMENT LENS WAS WITH A BACK-UP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO VITRECTOMY PERFORMED OR SUTURES USED. THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED AND THE PATIENT DID NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7119715 ↗
• MalfunctionAug 29, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN REMOVING FROM THE PACKAGE, A HAIR WAS FOUND ON THE INTRAOCULAR LENS (IOL). NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5912736 ↗