iSert Intraocular Lens 250 (clear), +23.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04547480480848), received between Aug 11, 2017 and Sep 15, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781859 ↗
• 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 21031315 ↗
• InjuryFeb 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HAS RECOVERED AND IS FINE. PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN. IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18774736 ↗
• InjuryNov 22, 2023Material 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 LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18196831 ↗
• InjuryNov 22, 2023Material 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 LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18196780 ↗
• MalfunctionJul 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PACKAGING PROBLEM; THERE IS UNKNOWN DEBRIS AT OPENING POUCH. NO PATIENT INVOLVEMENT. THE EVENT OCCURRED IN (B)(6). THERE WAS NO IMPACT TO THE PATIENT, HOWEVER IT WAS REPORTED TO THE (B)(6) BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136909 ↗
• InjuryFeb 18, 2021Material Opacification; Material Opacification

  IMPLANT DATE: (B)(6) 2018: POST-OPERATIVE COMPLICATIONS; OCCURRENCE OF PCO WITHIN 5 DAYS AFTER IMPLANTATION PCO HAS OCCURRED, PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED; VISUAL ACUITY DROPPED/IMPACTED, YAG LASER TREATMENT WAS DONE. (B)(4).

  Patient problems: Visual Impairment

  MAUDE report 11346044 ↗
• InjuryAug 11, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE LENS IN THE PATIENT'S RIGHT EYE, THE LENS DISLOCATED AND THERE WAS POSTERIOR CAPSULE TEAR/RUPTURE. THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY WITH A DIFFERENT MODEL IOL THAT WAS PLACED IN THE SULCUS. NO VITRECTOMY WAS PERFORMED. THE INCISION WAS NOT ENLARGED AND SUTURE WAS NOT REQUIRED. ACCORDING TO THE REPORTER, THE LIKELY CAUSE OF THE EVENT WAS "SURGICAL TECHNIQUE." CURRENT PATIENT PROGNOSIS WAS DESCRIBED AS "EXCELLENT PROGNOSIS."

  Patient problems: Capsular Bag Tear; Failure of Implant

  MAUDE report 6789230 ↗