iSert Intraocular Lens 250 (clear), +19.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04547480480763), received between Mar 23, 2016 and Nov 19, 2024 — classified as 6 injuries, 3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Optical Distortion; Optical Distortion

  EVENT OCCURRED IN CHINA. REDUCED DUE TO GLISTENING, OPTIC GLISTENING. PROBLEM CODE: A0604 - OPTICAL DISTORTION.

  Patient problems: Blurred Vision

  MAUDE report 20729714 ↗
• InjuryFeb 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA DAMAGED HAPTIC AFTER IMPLANTATION ROOT; BROKEN HAPTIC DURING USE; DAMAGED HAPTIC PATIENT HEALTH NOT IMPACTED PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Flashers

  MAUDE report 18774734 ↗
• InjuryJun 16, 2022Material Opacification; Material Opacification

  IMPLANT DATE: (B)(6) 2022, DATE OF EVENT: 11 MAR 2022, DATE PF EXPLANT: (B)(6) 2022. EVENT OCCURRED IN CHINA. MANUFACTURER'S DATE OF AWARENESS: (B)(6) 2022. POST-OPERATIVE COMPLICATIONS, CELL ADHESION. OPTIC OPACIFICATION PATIENT CONDITION AND SYMPTOMS: EYE PAIN, VISUAL IMPAIRMENT, FAILURE OF IMPLANT HEALTH IMPACT: DEVICE EXPLANTATION.

  Patient problems: Eye Pain; Failure of Implant; Visual Impairment

  MAUDE report 14712241 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION WERE PERFORMED SUCCESSFULLY UNDER TOPICAL ANESTHESIA IN THE RIGHT EYE. THE POSTOPERATIVE VISUAL ACUITY RECOVERED 4.90.5 8. ON (B)(6) 2021, THE PATIENT FELT THE SPOT SHADOW FLOATING IN FRONT OF THE RIGHT EYE. THE SHADOW IS KP - KERATIC PRECIPITATES, INFLAMMATORY CELLS OR PIGMENT DEPOSITS ON THE POSTERIOR SURFACE OF THE CORNEA. AFTER TREATMENT IN THE OPHTHALMOLOGY CLINIC THE PATIENT'S VISION RECOVERED TO 4.9 0.8 AND THE SPOT SHADOW FLOATING IN FRONT OF THE PATIENT'S EYES HAS DISAPPEARED. PATIENT HAS RECOVERED AND IS FINE.

  Patient problems: Visual Impairment

  MAUDE report 11922879 ↗
• InjuryMar 11, 2020Optical Decentration; Optical Decentration

  ACCORDING TO NADIA - OCULOPLASTIC FELLOW REPORTED LENS INFERIORLY DISPLACED. LENS CHANGED TO MA60AC, 18.50D. PATIENT IMPACT: VITRECTOMY, EXPLANTATION.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 9819394 ↗
• InjuryApr 26, 2019Break; Break

  SURGEON CHECKED LENS PRIOR TO INSERTION AND IT WAS FINE. ONCE INSERTION COMPLETE SURGEON BECAME AWARE THAT THE HAPTIC WAS DETACHED. THE LENS WAS REPLACED. PATIENT OUTCOME: NOTE ON COMPLAINT FORM: "NO PATIENT INJURY, LENS WAS REPLACED". NO ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8558453 ↗
• MalfunctionOct 9, 2018Break; Break

  WHEN THE LENS WAS IN THE EYE IT BECAME APPARENT, THAT HAPTIC WAS BROKEN. THE LENS HAD TO BE EXPLANTED AND NEW LENS PUT IN. PATIENT IMPACT: ONLY LENGTHENING OF PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949158 ↗
• InjuryJun 12, 2017Device Operates Differently Than Expected

  PATIENT CALLED REGARDING THE VISION IN HER LEFT EYE. SHE HAD A HOYA LENS IMPLANTED 5 MONTHS AGO. THE NEXT DAY POST-OP SHE HAD SEVERE PAIN IN HER EYE AND A GIANT BLUR. SHE HAD A YAG IN BOTH EYES WHICH HELPED THE SENSITIVITY TO LIGHT BUT DID NOT HELP THE BLUR OR THE PAIN. SHE HAD A SECOND OPINION BUT HER PAIN AND BLUR ISSUES STILL EXIST. NOW THE DOCTOR SAYS SHE HAS DRY EYE. HE SAID SHE NEEDS PRESCRIPTION GLASSES. THE RIGHT EYE WAS IMPLANTED FIRST AND SHE HAS 20/20 VISION POST-OP. THE SERIAL NUMBER WAS NOT PROVIDED NOR THE DATE OF EVENT.

  Patient problems: Blurred Vision; Dry Eye(s); Increased Sensitivity; Pain

  MAUDE report 6635474 ↗
• MalfunctionMar 23, 2016Break

  THE LEADING HAPTIC BROKE IN HALF. THE SURGEON NEEDED TO ENLARGE THE INCISION TO REMOVE THE IOL FROM THE PATIENT'S EYE. PATIENT PROGNOSIS IS REPORTED AS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5519829 ↗