SENSAR IOL AAB00 (REF AAB0000245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474548756), received between Jul 10, 2018 and Apr 23, 2025 — classified as 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT WAS PARTIALLY INSERTED IN THE PATIENT'S LEFT EYE WHEN THE PATIENT MOVED, THE IOL WAS REMOVED AND REPLACED DURING THE SAME SURGERY. THERE WAS NO INCISION ENLARGED, VITRECTOMY, OR SUTURE PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER). NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896613 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT PATIENT HAD A MYOPIC SURPRISE WITH INTRAOCULAR LENS (MODEL AAB00). ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT IOL WAS EXPLANTED DUE TO MYOPIC SURPRISE. THE LENS WAS REMOVED DURING A SECONDARY SURGERY WITH UNKNOWN INTRAOCULAR LENS (IOL). THE PATIENT IS SEEING 20/20 UNCORRECTED POST-LENS EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Visual Impairment

  MAUDE report 21877789 ↗
• MalfunctionJun 22, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE BECAUSE OF A SCRATCH ON THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14782998 ↗
• MalfunctionJan 31, 2019Break; Break

  IT WAS REPORTED THAT MODEL AAB00 MONOFOCAL IOL (INTRAOCULAR LENS) WAS DAMAGED. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Information

  MAUDE report 8295215 ↗
• InjuryJul 10, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT INTRAOCULAR LENS WAS REMOVED AND REPLACED FROM PATIENT¿S OPERATIVE EYE IN THE SAME SURGICAL PROCEDURE BECAUSE OF PATIENT¿S LARGE ZONULAR DEHISCENCE DUE TO WHICH LENS WAS TILTED. DURING THE PROCEDURE INCISION WAS ENLARGED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS NO ISSUE WITH THE LENS BUT THERE WAS ANATOMICAL ISSUE WITH THE PATIENT. PATIENT HAD A LOOSE ZONULES DUE TO WHICH AFTER THE LENS WAS IMPLANTED DOCTOR OBSERVED THAT LENS WAS NOT SECURE AND HAD POSITIONING ISSUE SO THE LENS WAS REMOVED AND REPLACED. CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY. PATIENT IS DOING GOOD. NO FURTHER INFORMATION.

  Patient problems: No Code Available; Zonular Dehiscence

  MAUDE report 7674896 ↗