iSert Intraocular Lens 250 (clear), +18.50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04547480480756), received between Apr 3, 2017 and Apr 2, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. UPDATED BY MARCH 10: AFTER IMPLANTATION, THE POSITION OF THE IOL IS NOT VERY GOOD AND THE HAPTIC WAS SEPARATED FROM THE IOL. THE DOCTOR WENT ON TO COMPLETE THE OPERATION WITH A NEW PRODUCT. PATIENT HAS RECOVERED AND IS FINE. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 21758951 ↗
• InjuryDec 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 21031255 ↗
• InjuryMay 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  EVENT OCCURRED IN INDIA. ORIGINALLY ASSESSED AS NOT REPORTABLE PER MVPI INDIA GUIDELINE, (B)(6) 2020. OVD USED WAS REPORTED AS "UNKNOWN." TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS REPORTED. IMPLANT DATE: (B)(6) 2021; ONSET WITHIN 5 DAYS AFTER IMPLANTATION PATIENT IMPACT: PATIENT HAS RECOVERED AND IS FINE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 17015037 ↗
• InjuryJul 21, 2017Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LENS HAPTIC TORE THE CAPSULAR BAG WHILE BEING IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6734385 ↗
• InjuryMay 22, 2017Break

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO IMPLANT THE LENS BUT CAPSULE WAS BROKEN. THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED. A SULCUS LENS WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6581972 ↗
• MalfunctionApr 3, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS REMOVED INTRAOPERATIVELY FROM THE PATIENT'S LEFT EYE DUE TO A SMALL CAPSULE TEAR NOTED UPON INSERTION. ANOTHER LENS OF DIFFERENT MODEL WAS IMPLANTED SUCCESSFULLY AND THE PROGNOSIS WAS REPORTED AS "GOOD."

  Patient problems: Capsular Bag Tear

  MAUDE report 6455450 ↗