iSert Intraocular Lens 251 (yellow), +21.50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04547480450322), received between May 3, 2019 and Apr 9, 2024 — classified as 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING HAPTIC DOES NOT FOLD AS PER IFU. PRODUCT REPLACED IMMEDIATELY WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. IOL WAS EXPLANTED ON (B)(6) 2024 IMDRF CODE: (B)(6), MATERIAL SPLIT CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 19076699 ↗
• InjurySep 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN NEW ZEALAND. DAMAGED HAPTIC AFTER IMPLANTATION. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 17802315 ↗
• InjuryJul 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED HAPTIC AFTER IMPLANTATION PROBLEM CODE: A0414 MATERIAL SPLIT CUT OR TORN IMPLANT DATE: (B)(6) 2020. EXPLANT DATE: (B)(6) 2020. PATIENT IMPACT: DEVICE EXPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 17297466 ↗
• InjuryJul 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED HAPTIC AFTER IMPLANTATION. PROBLEM CODE: A0414 MATERIAL SPLIT, CUT OR TORN. IMPLANT DATE: (B)(6)2020. EXPLANT DATE: (B)(6)2020. PATIENT IMPACT: DEVICE EXPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 17255826 ↗
• InjuryJul 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTED CASE OF INFLAMMATION / UVEITIS IN MEXICO. DATE OF SURGERY - NOT PROVIDED. DATE OF EVENT - NOT PROVIDED. ON 23-MAY-2022: MANUFACTURER'S DATE OF AWARENESS. ON 15-JUN-2022: AUTHORIZED COUNTRY REPRESENTATIVE ASSESSED AS A REPORTABLE EVENT TO COFEPRIS BY END OF YEAR.

  Patient problems: Uveitis

  MAUDE report 14989164 ↗
• MalfunctionJul 22, 2019Break; Break

  BOTH LENSES WERE PREPARED CORRECTLY USING ADEQUATE AND CORRECT AMOUNT OF HELAON. AFTER INJECTION AND LENS UNFOLDING, CHIPS WERE NOTICED MISSING FROM THE OPTICS. THE LENSES WERE NOT EXPLANTED AS RISK TO THE PATIENT WAS CONSIDERED HIGHER IF EXPLANTING RATHER THAN LEAVING IN SITU. NO PATIENT IMPACT YET, BUT SHARP EDGES OF CHIPS IS CONCERNING AS COULD CAUSE PC RUPTURE AS CAPSULAR BAG SHRINKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8813120 ↗
• InjuryMay 3, 2019Break; Break

  REPORT FROM THE NURSE: WHEN I ADVANCE THE IMPLANT I NOTICED THE BACK HAPTIC WAS TRAILING, WHEN THE LENS WAS INJECTED THE BLUE TIP OF THE HAPTIC CAME OFF AND REMAINED IN THE CHAMBER. THE SURGEON REMOVED THE LENS FROM THE PATIENTS EYE AND SUCCESSFULLY IMPLANTED ANOTHER LENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579798 ↗