iSert Intraocular Lens 250 (clear), +24.50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547480480879), received between May 8, 2017 and Feb 22, 2021 — classified as 4 injuries.

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 18, 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.

• InjuryFeb 22, 2021Break; Break

  BROKEN HAPTIC DURING USE; ALL STEPS WERE FINE; AT THE END OF IMPLANTATION THE HAPTIC BROKE OFF. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HAS RECOVERED AND IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362596 ↗
• InjuryMay 3, 2019Break; Failure to Fold; Break; Failure to Fold

  TRAILING HAPTIC IS NOT FOLDED CORRECTLY. IMPLANTATION IS DONE - BUT THE HAPTIC BREAKS OFF AND THE LENS MUST BE CUT AND REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579810 ↗
• InjuryFeb 2, 2018Device Operates Differently Than Expected

  THE TRAILING HAPTIC FAILED TO MOVE DOWN, TRAPPED WITHIN THE CARTRIDGE. THE HAPTIC HAD TO BE CUT THE AS THE** WAS ALREADY IN THE BAG AND THE IOL COULD NOT BE RELEASED FROM THE CARTRIDGE. A LOT OF EXTRA AND TOTALLY UNNECESSARY MANIPULATION INSIDE THE AC TO DISLOCATE THE LENS. TO CUT AND REMOVE THE LENS THE INCISION NEEDED TO BE INCREASED AND 2 EXTRA SUTURES. NOT A VERY GOOD EXPERIENCE. PATIENT IMPACT: LENGTHENING OF PROCEDURE. PATIENT OUTCOME: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 7239328 ↗
• InjuryMay 8, 2017Malposition of Device

  IT WAS REPORTED THAT CAPSULE TORE WHILE THE SURGEON IMPLANTED A HOYA LENS. THE SURGEON HAD TO REMOVE THE HOYA LENS, PERFORMED VITRECTOMY, AND THEN PROCEEDED TO IMPLANT A SOFPORT LENS. IT IS UNKNOWN WHY THE SOFPORT LENS WAS ALSO PULLED OUT. THE SURGEON PERFORMED VITRECTOMY AGAIN AND ENDED UP IMPLANTING A DIFFERENT BRAND LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 6552891 ↗