iSert Intraocular Lens 250 (clear), +22.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04547480480824), received between Apr 5, 2016 and May 9, 2025 — classified as 8 injuries, 3 malfunctions.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. DAMAGED HAPTIC AFTER IMPLANTATION AND REQUIRED EXPLANTATION. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 21999013 ↗
• 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 21031300 ↗
• InjuryNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; TIP; DAMAGED HAPTIC. 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 20789339 ↗
• InjuryNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; TIP; DAMAGED HAPTIC. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 20787561 ↗
• InjuryDec 18, 2020Optical Decentration; Optical Decentration

  RETURNED IMPLANT CARD STATES "LENS BECAME DISLOCATED IN THE EYE - WILL BE REMOVED AT A LATER DATE." DISTRIBUTOR MADE SEVERAL ATTEMPTS TO GATHER MORE INFORMATION, BUT WAS UNSUCCESSFUL. NO OTHER INFORMATION AVAILABLE. DATE EXPLANTED IS NOT KNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11038485 ↗
• InjuryJun 11, 2019Break; Break

  TORN HAPTIC - IOL HAD TO BE EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689703 ↗
• MalfunctionJun 11, 2019Break; Break

  TRAINING HAPTIC WAS TORN OFF IN INJECTOR AND REMAINED THERE AS THE REST OF THE IOL WAS STABLE AND WOULD CAUSE NO HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689700 ↗
• MalfunctionJun 11, 2019Break; Break

  THE TRAINING HAPTIC FELL OFF. LENS HAS BEEN LEFT IN PATIENTS EYE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689684 ↗
• InjuryJan 11, 2018Insufficient Device Problem Information

  THE SURGEON REMOVED A FRAGMENT OF HAPTIC FROM THE IOL IMPLANT FROM THE ANTERIOR CHAMBER. PATIENT HAD CATARACT SURGERY ON (B)(6) 2017, NO PROBLEMS NOTED AT THE TIME BUT ON REVIEW APPOINTMENT APPARENT THAT THE CORNEA WAS OEDEMATOUS. SUBSEQUENTLY REFERRED TO DR. FOR OPINION AND APPARENT THAT THERE WAS A BLUE END OF THE HAPTIC OF THE LENS IMPLANT IN THE FRONT CHAMBER OF THE EYE. THERE HAVE BEEN OTHER OCCURRENCES OF THE BACK HAPTIC TEARING OFF WHILE BEING INJECTED, BUT WAS OBVIOUSLY DAMAGED AT THE TIME BUT NOT APPARENT, AND IT HAS SUBSEQUENTLY BECOME COMPLETELY DETACHED AND LOOSE IN THE ANTERIOR CHAMBER, DAMAGING THE ENDOTHELIAL CELLS AND CAUSING THE CORNEA TO BECOME CLOUDY. PATIENT INFORMATION- PATIENT OUTCOME REMAINS UNKNOWN, HOWEVER ACTION TAKEN BY THE HEALTHCARE FACILITY TO THE CARE OF THE PATIENT: REMOVING THE FRAGMENT TO PREVENT FURTHER DAMAGE WAS THE FIRST STEP. THE CORNEA HAS CLEARED SOMEWHAT SINCE. TIME WILL TELL WHETHER THE CORNEA WILL CLEAR FULLY, OR IF THE PATIENT WILL REQUIRE AN ENDOTHELIAL CORNEAL TRANSPLANT.

  Patient problems: Clouding, Central Corneal; Eye Injury

  MAUDE report 7183354 ↗
• InjuryMay 8, 2017Break

  IT WAS REPORTED THAT THERE WAS A BROKEN CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6552133 ↗
• MalfunctionApr 5, 2016Insufficient Device Problem Information

  REPORT STATED POSTERIOR CAPSULE RUPTURE THAT OCCURRED RIGHT AFTER IOL IMPLANTATION. PATIENT PROGNOSIS IS REPORTED AS GOOD, AND THE SURGEON DID NOT NEED TO ENLARGE THE INCISION TO REMOVE THE IOL.

  Patient problems: Rupture

  MAUDE report 5548107 ↗