iSert Intraocular Lens 251 (yellow), +21.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547480450315), received between Oct 19, 2018 and Jul 18, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. BROKEN HAPTIC DURING USE 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 17347738 ↗
• MalfunctionDec 5, 2019Break; Break

  PEELING HAPTIC DURING USE. PATIENT IMPACT: NO IMPACT. IT OCCURRED IN CHINA, THERE WAS NO IMPACT TO PATIENT, BUT IT WAS REPORTED AS AE TO LOCAL AUTHORITY BY HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9419427 ↗
• MalfunctionJul 23, 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 8817558 ↗
• MalfunctionJan 25, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  LEADING HAPTIC DID NOT FOLD PROPERLY AND WAS TRAPPED BETWEEN PLUNGER AN THE CARTRIDGE TIP, SO THE HAPTIC TORN OFF. LENS HAD TO BE EXPLANTED (NO PATIENT IMPACT). NEW LENS WAS IMPLANTED. SECOND IMPLANTATION WENT WELL WITHOUT HARMING THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8278763 ↗
• MalfunctionOct 19, 2018Break; Break

  REALIZED THERE WAS A CHIP IN THE LENS AND CUT IT OUT OF PATIENTS EYE AND PUT ANOTHER IN. NEW LENS HAD TO BE IMPLANTED BUT WITHOUT HARMING THE PATIENT. PATIENT IMPACT: ONLY LENGTHENING OF PROCEDURE. PATIENT OUTCOME: NO IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7985670 ↗