SENSAR IOL AAB00 (REF AAB0000160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474548589), received between Mar 15, 2017 and Feb 9, 2026 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300449 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT THE SURGEON NOTICED A CRACK ON THE TRAILING HAPTIC OF THE INTRAOCULAR LENS (IOL) AFTER IT WAS FULLY INSERTED, IMPLANTED INTO PATIENT'S RIGHT EYE. IT WAS CONFIRMED THAT THE TRAILING HAPTIC WAS BROKEN AFTER IT WAS EXAMINED UNDER THE MICROSCOPE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15424811 ↗
• MalfunctionApr 6, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC LEG OF THE INTRAOCULAR LENS (IOL) REMAINED INSIDE THE INJECTOR DETACHED FROM THE IOL. IT WAS REPORTED THAT THE IOL WAS INCORRECTLY PLACED AND HAD TO BE EXPLANTED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624161 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO AN INCORRECT LENS POWER. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS (SAME MODEL AND DOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9753824 ↗
• MalfunctionJul 8, 2019Contamination; Contamination

  REPORTEDLY, A PLASTIC STRING WAS FOUND AROUND A AAB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) UPON IMPLANTATION. THE SURGEON WAS ABLE TO REMOVE THE STRING WITHOUT HARM TO THE PATIENT. THE LENS REMAINS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE. THERE IS NO INDICATION THAT THE PATIENT'S VISUAL IS EFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8770043 ↗
• MalfunctionMar 15, 2017Sticking; Sticking

  IT WAS REPORTED THAT AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE OF A MALE PATIENT, THE TRAILING HAPTIC WAS STUCK TO THE LENS AND WOULD NOT LET GO. REPORTEDLY, IT TOOK SEVERAL MINUTES FOR THE SURGEON TO RELEASE IT. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED. THE LENS REMAINED IMPLANTED. THROUGH FOLLOW UP ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON. AFTER HE WAS ABLE TO PRY THE HAPTIC OFF WHICH TOOK ABOUT 10 MINUTES HE WAS THEN ABLE TO PUT THE IOL BACK INTO THE INTACT BAG. THE PATIENT DID NOT SUFFER ANY COMPLICATIONS. THERE WAS NO VITREOUS LOSS. HE LOOKED FINE AT DAY ONE AND ONE WEEK. HE WILL BE SEEN AGAIN IN A MONTH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6405075 ↗