SENSAR IOL AAB00 (REF AAB0000145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474548558), received between Feb 13, 2017 and Mar 19, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE BOX WAS OPENED, IT WAS FOUND THAT THE STERILE BAG PACKAGING WAS PERFORATED, PARTLY WITH A HOLE. THEREFORE, THE LENS WAS NOT USED AT ALL AND A NEW ONE WAS TAKEN. THERE WAS NO CONTACT WITH THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826911 ↗
• MalfunctionFeb 13, 2017Sticking; Appropriate Device Problem Term/Code Not Available; Sticking; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD THE HAPTIC STUCK TO THE OPTIC AND THE OPTIC HAD SPOTS ALL OVER IT. REPORTEDLY, THE ISSUE WAS CONFIRMED BY THE ACCOUNT UNDER THE MICROSCOPE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE HAPTIC WAS STUCK TO THE OPTIC IN THE PACKAGING AND THE LENS NEVER LOADED IN THE CARTRIDGE. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6326129 ↗