iSert Intraocular Lens 250 (clear), +20.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04547480480787), received between Feb 9, 2018 and Mar 28, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: Failure of Implant

  MAUDE report 18994362 ↗
• InjuryNov 22, 2023Failure to Eject; Failure to Eject

  EVENT OCCURRED IN MALAYSIA. IOL GOT STUCK DURING SCREW ROTATION DUE TO INJECTOR MALFUNCTION DURING IOL INSERTION IMDRF CODE: A050301, FAILURE TO EJECT. IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18196907 ↗
• InjuryJul 20, 2022Sharp Edges; Sharp Edges

  DAMAGED HAPTIC AFTER IMPLANTATION. IT WAS NOTED THAT BSS WAS USED. INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. A CAPSULAR BAG RUPTURE, EMERGENCY ANTERIOR VITRECTOMY, SULCUS LENS AND FOLLOW-UP IN AN OPTHALMIC CLINIC. THE PATIENT HAS RECOVERED AND IS FINE.

  Patient problems: Capsular Bag Tear; Failure of Implant

  MAUDE report 15066776 ↗
• InjuryDec 18, 2020Break; Break

  CRACKED OPTIC RESULTING IN A VERTICAL LINE THROUGH MIDDLE OF OPTIC. PLAN IS TO EXCHANGE LENS ON MARCH 23RD. IT WAS REPORTED THAT THE SURGEON HAS EXPERIENCED SOME "CRACKING" IN THE IOL AFTER/DURING IMPLANTATION. THE SURGEON SHALL BE RETURNING TO THE O.R, EXPLANTING THE IOL AND REPLACING IT WITH A DIFFERENT MANUFACTURER'S IOL. THIS PATIENT IS NOW EXPERIENCING A "LINE" IN THEIR VISION NOTED ON LOOKING AT BRIGHT LIGHTS AND HEADLIGHTS, ALTHOUGH ACUITY IS QUITE GOOD AND EXCEPT FOR A LINEAR DEFECT IN THE IMPLANT EVERYTHING LOOKS EXCELLENT. THE LENS WILL BE EXPLANTED ON MARCH 23RD.

  Patient problems: Visual Disturbances

  MAUDE report 11038472 ↗
• InjuryMar 23, 2020Sharp Edges; Sharp Edges

  EDGE OF LEADING IOL HAPTIC SEEMS TO BE SHARP/IRREGULAR AND HAS CUT THE INFERIOR EQUATOR OF THE LENS CAPSULE DURING ASPIRATION OF VISCOELASTIC AT THE END OF THE CATARACT SURGERY PROCEDURE. IOL APPEARED TO BE CENTRED AT CONCLUSION OF CATARACT SURGERY BUT REVIEW 1 WEEK LATER SHOWS THE INTRAOCULAR LENS HAS DECENTERED INFERIORLY, CAUSING MONOCULAR DIPLOPIA AND BLURRED VISION. EXPLANATION TO PATIENT AND FAMILY THAT THE INTRAOCULAR LENS IMPLANT HAS DECENTERED INFERIORLY AND NEEDS TO BE EXCHANGED. MANUFACTURER INFORMED. INTRAOCULAR LENS REMOVAL, ANTERIOR VITRECTOMY AND SULCUS INTRAOCULAR LENS IMPLANTED (B)(6) 2020. PROCEDURE WENT SMOOTHLY.

  Patient problems: Capsular Bag Tear

  MAUDE report 9866575 ↗
• MalfunctionSep 9, 2019Break; Break

  CRACKED OR BROKEN OPTIC. NOTED IN SURGERY ROOM. NO PATIENT IMPACT. EVENT OCCURRED IN (B)(6). THERE WAS NO IMPACT TO PATIENT, BUT IT WAS REPORTED BY HOSPITAL AS AE TO (B)(6) AUTHORITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8976730 ↗
• InjuryMay 3, 2019Break; Break

  THE TRAILING HAPTIC WAS DETACHED WHEN IOL WAS INJECTED INTO THE EXE - IOL WAS REMOVED AND SUCCESSFULLY REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579889 ↗
• InjuryMay 3, 2019Break; Failure to Unfold or Unwrap; Break; Failure to Unfold or Unwrap

  HAPTIC DID NOT OPEN AND SNAPPED OFF WHEN INSERTING THE LENS. THEREFORE HAD TO BE CUT TO REMOVE THE LENS. THE PATIENT FELT SOME DISCOMFORT AND PAIN WHEN ATTEMPTING TO REMOVE THE SNAPPED HAPTIC AND LENS.

  Patient problems: Pain

  MAUDE report 8579815 ↗
• InjuryApr 26, 2019Failure to Fold; Failure to Fold

  WHEN PREPARING THE LENS, FILLED UP WITH HEALON 10MG/ML; IT LOOKED NORMAL. WHEN TRYING TO INSERT THE LENS, NOTICED THE TRAILING HAPTIC WASN´T FOLDED CORRECTLY. THEY HAD TO REMOVE THE LENS FROM THE INCISION AND OPEN UP AND REPEAT WITH A NEW LENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8558517 ↗
• InjuryFeb 9, 2018Air Leak; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED PERFORMING A LENS EXCHANGE DUE TO BUBBLES IN THE LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7259622 ↗