iSert Intraocular Lens 250 (clear), +19.50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04547480480770), received between Jul 28, 2017 and Jan 20, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2026Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. THE CAUSE WAS THAT AN INSUFFICIENT AMOUNT OF VISCOELASTIC WAS INJECTED DURING SURGERY, WHICH RESULTED IN THE HAPTIC BEING CLAMPED BEFORE THE LENS IMPLANTATION. THE SURGEON THEN FORCIBLY PUSHED THE LENS FORWARD, CAUSING THE INJECTOR TIP TO FRACTURE. AFTER DISCOVERING THE BROKEN HAPTIC, THE SURGEON REMOVED THE LENS AND IMPLANTED A NEW ONE. CURRENTLY, THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE CONDITIONS POSTOPERATIVELY. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED; IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 24126035 ↗
• InjuryDec 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE. CORNEAL EDEMA. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 21031299 ↗
• 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 21029356 ↗
• InjuryApr 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. MIDDLE; DAMAGED HAPTIC. PATIENT HAS RECOVERED AND IS FINE. IOL WAS EXPLANTED ON (B)(6) 2023. PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 19188462 ↗
• InjuryJan 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA DAMAGED HAPTIC AFTER IMPLANTATION IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN INCREASED INCISION SIZE; PRODUCT REPLACED WITH ANOTHER LENSIMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18530130 ↗
• InjuryNov 16, 2023Scratched Material; Scratched Material

  EVENT OCCURRED IN CHINA. DAMAGED OPTIC AFTER IMPLANTATION. IMDRF CODE: (B)(6), SCRATCH MATERIAL. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18156808 ↗
• InjuryJun 11, 2019Break; Break

  AFTER THE LENS WAS INSERTED INTO THE PATIENTS EYE, THE SURGEON NOTICED A CHUP IN THE OPTIC. ONE OF OUR DISTRIBUTOR'S REPRESENTATIVES WAS PRESENT FOR THE OPERATION, SO PROPER LUBRICATION WAS USED. THE LENS HAD TO BE CUT FROM THE PATIENTS EYE AND REPLACED WITH ANOTHER LENS. THE PLUNGER TIP LOOKS DAMAGED. PHOTOGRAPHS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689709 ↗
• MalfunctionJun 11, 2019Break; Break

  TIP OF THE TRAINING HAPTIC TORE OFF IOL AND WAS LEFT IN THE INJECTOR. IOL WAS ALREADY ADVANCED AND INJECTED. IOL WAS STABLE AND SURGEON WAS HAPPY TO LEAVE IMPLANTED. WILL FOLLOW UP AS ROUTINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689673 ↗
• InjuryMay 10, 2019Break; Break

  THE LENS WAS IMPLANTED ROUTINELY, IT WAS THEN NOTICED BY THE SURGEON THAT THE TRAILING HAPTIC HAD NOT COME OUT OF THE INJECTOR AND HAD BEEN RIPPED AWAY FROM THE OPTIC. THE LENS THEN HAD TO BE CUT IN HALF WHICH HAD THE POTENTIAL TO CAUSE DAMAGED TO THE INTERNAL STRUCTURE. LENS REMOVAL CAUSING ENDOTHELIAL CELL LOSS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8600996 ↗
• InjurySep 22, 2017Material Rupture; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON RUPTURED THE POSTERIOR CAPSULE DURING LENS MANIPULATION IN THE LEFT EYE. LENS HAD TO BE REMOVED AND REPLACED WITH ANOTHER MODEL LENS. VITRECTOMY WAS PERFORMED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6887425 ↗
• InjuryJul 28, 2017Malposition of Device

  THE CONSUMER REPORTED HAVING CATARACT SURGERY, AND THE AFTERNOON AFTER THE SURGERY THE SURGEON LOOKED AT THIS EYE AND REPORTEDLY SAID THE LENS IS NOT POSITIONED PROPERLY. THE CONSUMER WAS REFERRED TO ANOTHER DOCTOR TO HAVE THE LENS REPOSITIONED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 6752566 ↗