iSert Intraocular Lens 230 (clear), +22.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547480301358), received between Apr 11, 2018 and Apr 1, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2021Material Twisted/Bent; Material Twisted/Bent

  DEFORMED HAPTIC AFTER IMPLANTATION. THE HAPTIC WAS BENT. DEVICE EXPLANTATION. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; NO INCISION ENLARGEMENT OR SUTURES WERE NECESSARY. ANOTHER LENS WAS OBTAINED AND IMPLANTED SUCCESSFULLY. PATIENT HEALTH NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606160 ↗
• InjuryApr 11, 2018Torn Material

  ON (B)(6) 2018, DISTRIBUTOR ((B)(4)) NOTIFIED MANUFACTURER THAT: "IT WAS REPORTED THAT THE LENS HAS MALFUNCTIONED UPON INSERTION, THE LENS TORE. NO OTHER INFORMATION AVAILABLE." "THE DATE OF EVENT IS 'UNKNOWN' AND BASED ON THE AVAILABLE INFORMATION THE EVENT HAS BEEN ASSESSED BY (B)(4) AS 'NOT REPORTABLE'." ON (B)(6) 2018, DISTRIBUTOR ((B)(4)) NOTIFIED MANUFACTURER OF UPDATED INFORMATION, AS FOLLOWS: "UPDATED 04/05/2018: IT WAS REPORTED THAT A LENS TEAR ALONG THE OPTIC EDGE DURING INSERTION. USING AN INJECTOR THROUGH THE SUPERIOR TEMPORAL INCISION, AS THE POSTERIOR CHAMBER IOL WAS BEING INSERTED, IT WAS NOTED TO HAVE A TEAR ALONG THE OPTIC EDGE EXTENDING FROM THE LEADING HAPTIC INSERTION. AS THE IMPLANT WAS INFOLDING, THE WOUND WAS INCREASED TO 5 MM; THE OPTIC WAS ELEVATED OUT OF THE CAPSULAR BAG INTO THE ANTERIOR CHAMBER THEN COMPLETELY REMOVED IN 2 PIECES. A SECOND SAME LENS WAS INSERTED WITH THE HAPTIC BEING PLACED DIRECTLY IN THE CAPSULAR BAG. THE OPTIC NOTED TO CENTER WELL WITH THE HAPTIC LEFT AT THE 6 AND 12 POSITIONS AND SUTURES WERE USED AS PART OF THE STANDARD PROCEDURE. AN INFERIOR SUBCONJUNCTIVAL INJECTION OF GENTAMICIN IT WAS GIVEN UNDER DIRECT VISUALIZATION. THE PATIEN

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7423949 ↗