SENSAR IOL AAB00 (REF AAB0000150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474548565), received between Nov 7, 2018 and Mar 13, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS CHIPPED DURING THE LOADING PROCESS. THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE AND THEN THE SURGEON NOTICED THAT THE LENS WAS CHIPPED. THE LENS WAS THEN REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (ZCB00, +15.0 DIOPTER, AS NO ADDITIONAL AAB00 MODEL LENS WAS AVAILABLE AT THE TIME) DURING THE SAME PROCEDURE. THERE WAS NO HARM DONE TO THE PATIENT DURING THE SURGERY. THE PATIENT STATUS IS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899252 ↗
• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A CRACK GOING DOWN THE MIDDLE AND THIS CRACK WAS NOT OBSERVED UNTIL THE LENS WAS INSERTED INTO THE PATIENT'S RIGHT EYE. THE LENS WAS CUT OUT FROM THE EYE AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13674388 ↗
• MalfunctionFeb 4, 2019Break; Break

  IT WAS REPORTED THAT UPON OPENING THE INTRAOCULAR LENS CONTAINER, IT WAS OBSERVED THAT THE OUTER EDGE OF THE IMPLANT WAS CRIMPED. THE SURGEON EVALUATED THE DEVICE UNDER THE MICROSCOPE AND FOUND THAT THE IMPLANT WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8300638 ↗
• InjuryNov 7, 2018Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE AAB00 SENSAR MONOFOCAL IOL INTO THE PATIENT'S OPERATIVE EYE, THE SURGEON NOTICED THAT THE LENS HAD RINGS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT HAD AN UNEXPECTED POST-OP REFRACTION AND THEIR VISION WAS (B)(6) 2018. REPORTEDLY, THE ACCOUNT COMMENTED THAT THE PATIENT'S CORNEA IS NOT FIT TO GO FOR A SECONDARY SURGICAL INTERVENTION; THEREFORE THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8046885 ↗