iSert Intraocular Lens 250 (clear), +18.00DRecalls & reported problems
Hoya Medical Singapore Pte. Ltd. · Class 3 · Implant
All models of iSert Intraocular Lens (69)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04547480480749), received between Dec 7, 2015 and Jul 30, 2025 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break4
- Detachment Of Device Component2
- Material Split, Cut or Torn2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant3
- No Code Available2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING. WOUND STRETCH; INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 22672098 ↗InjuryDec 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE. CORNEAL EDEMA. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. PATIENT HAS RECOVERED AND IS FINE. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 21031282 ↗InjuryMay 24, 2022Break; Break
DAMAGED HAPTIC AFTER IMPLANTATION. TORN TRAILING HAPTIC. DEVICE EXPLANTED. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED.
Patient problems: Failure of Implant
MAUDE report 14482099 ↗MalfunctionNov 7, 2018Break; Break
TRAILING HAPTIC EXTENDED AFTER LOADING, SURGEON INFORMED AND CHECKED LENS, SURGEON INSERTED LENS BUT TRAILING HAPTIC SNAPPED. SO IT WAS REMOVED AND NEW LENS INSERTED. NEW LENS WAS IMPLANTED WITHOUT ANY COMPLICATION. PATIENT IMPACT: ONLY LENGTHENING OF PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8049156 ↗InjuryJul 28, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A LENS HAS BEEN EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.
Patient problems: No Code Available
MAUDE report 6751947 ↗MalfunctionDec 7, 2015Break; Detachment Of Device Component
THE TRAILING HAPTIC SNAPPED OFF WHEN THE DOCTOR WAS INJECTING THE LENS INTO THE EYE. THIS IS THE SECOND LENS THAT WAS IMPLANTED INTO THIS PATIENT WITH THE SAME OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5271928 ↗MalfunctionDec 7, 2015Break; Detachment Of Device Component
THE TRAILING HAPTIC SNAPPED OFF WHEN THE DOCTOR WAS INJECTING THE LENS INTO THE EYE. THE INCISION WAS WIDENED IN ORDER TO EXPLANT THE LENS.
Patient problems: No Code Available
MAUDE report 5271923 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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