SENSAR IOL AAB00 (REF AAB0000235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474548732), received between Feb 20, 2017 and Oct 24, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A POSTERIOR CAPSULE TEAR WITH A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). PATIENT CONTACT IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23384594 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS FOLDED. DURING AND POST INSERTION OF THE IOL INTO THE RIGHT EYE, IT WAS NOTICED THAT THE IOL WAS FOLDED. THE LENS WAS IMPLANTED AND THE INCISION WAS ENLARGED TO REMOVE IT. DURING THE SAME PROCEDURE THE LENS WAS REMOVED. THERE WAS A DELAY IN PROCEDURE. NO VITRECTOMY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A NON-JNJ IOL. BRAND NAME LUCIA, MODEL 221. THE PATIENT¿S PRE-OP VISION IS 20/400 AND POST-OP IS 20/30. THE PATIENT¿S DAILY ACTIVITIES WERE NOT IMPACTED BY THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19486248 ↗
• MalfunctionNov 30, 2023Difficult to Fold, Unfold or Collapse; Scratched Material; Ejection Problem; Difficult to Fold, Unfold or Collapse; Scratched Material; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) LENS DID NOT UNFOLD AT THE TIME OF IMPLANTATION IN THE PATIENT'S LEFT EYE, AND AS A RESULT, IT BECAME STUCK IN THE INCISION. THE DOCTOR ATTEMPTED TO REPOSITION IT; HOWEVER, DURING AN INSPECTION, HE NOTICED THAT IT WAS MARKED IN THE OPTICAL ZONE. IT WAS NECESSARY TO USE ANOTHER LENS THAT WAS AVAILABLE FOR THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE BACK-UP LENS. PATIENT RECOVERED, NO HARM TO THE PATIENT. THERE WAS NO POSTOPERATIVE INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238051 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM PATIENT'S OPERATIVE EYE IMMEDIATELY AFTER IMPLANTING AS THE SURGEON NOTICED THAT THE CAPSULE HAD TORN. IT WASN'T SURE IF IT WAS TORN BEFORE IMPLANTING THE LENS OR IF IT HAPPENED DURING LENS INSERTION. A THREE-PIECE LENS (ZA9003) OF SAME DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT IS DOING WELL WITH NO FURTHER COMPLICATIONS. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 14849355 ↗
• MalfunctionApr 7, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A HAPTIC DEFECT. THE CUSTOMER REPORTED THAT THE HAPTIC DETACHED ITSELF FROM THE LENS, "VERY PROBABLY DURING FOLDING" AND THAT THERE WAS PATIENT CONTACT. THE CUSTOMER REPORTED THAT THEY DO NOT HAVE MORE INFORMATION OTHER THAN WHAT IS PROVIDED. THE CUSTOMER CONFIRMED THAT THE LENS WAS DISCARDED. THROUGH FOLLOW UP IT WAS LEARNED THAT A NEW LENS (SAME MODEL/DIOPTER) WAS USED. THERE WERE NO COMPLICATIONS AND THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048641 ↗
• InjurySep 9, 2020Break; Failure to Unfold or Unwrap; Break; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE AND IT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE AS THE HAPTIC WAS BENT AND WOULD NOT UNFOLD. THE ISSUE WAS NOTED AFTER THE LENS WAS INSERTED. A LENS OF A DIFFERENT MODEL, ZA9003 AND DIOPTER (23.5) WAS USED AS THE REPLACEMENT. THERE WAS INCISION ENLARGEMENT AND A PARTIAL VITRECTOMY WAS REQUIRED. ADDITIONALLY, IT WAS INDICATED THAT SUTURES WERE REQUIRED, BUT THE NUMBER OF SUTURES USED IS UNKNOWN. REPORTEDLY, EVERYTHING WENT WELL WITH THE PATIENT AND NO INJURY WAS REPORTED. IT WAS NOTED THAT THE IOL HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 10505941 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS CUT OUT, REMOVED DURING THE SAME PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT LENS. REPORTEDLY, THE INCISION WAS ENLARGED, HOWEVER, THERE WAS NO OTHER PATIENT INJURY AND THE PATIENT IS DOING FINE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE LENS WAS REMOVED AND REPLACED DUE TO A LOADING ERROR AND WAS NOT OBSERVED UNTIL THE LENS WAS IN THE EYE. THE LENS WAS DISCARDED. ANOTHER LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8656870 ↗
• InjuryMar 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A MARK ON AN AAB00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED BY THE DOCTOR AFTER THE LENS WAS INSERTED INTO THE EYE. AN INCISION ENLARGEMENT WAS PERFORMED TO EXTRACT THE LENS AND ANOTHER SENSAR 1-PIECE LENS WAS IMPLANTED. THE INCISION WAS THEN CLOSED WITH A SUTURE. REPORTEDLY, THERE WAS NO SIGNIFICANT TIME ADDED TO THE SURGERY. THERE WAS NO VITRECTOMY PERFORMED. ALSO, THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITH NO IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7345868 ↗
• InjuryFeb 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AAB00 INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED A -2 DIOPTER DIFFERENCE POSTOP. THROUGH FOLLOW UP IT WAS LEARNED THE PHYSICIAN OBSERVED THAT AT THE SUPERIOR POSITION, ONE OF THE LENS HAPTICS SEEMED NOT TO BE IN THE CAPSULAR BAG AS PLANNED. IT WAS ALSO NOTED THE HAPTIC COULD BE IN THE SULCUS POSITION. THIS ISSUE COULD HAVE POTENTIALLY CAUSED THE MYOPIC REFRACTIVE SURPRISE. WITH THIS IT HAS LESS POSSIBILITY OF HAVING A MISLABELING PROBLEM. THE PHYSICIAN PLANS TO EXPLANT THE LENS.

  Patient problems: No Code Available

  MAUDE report 6344338 ↗