iSert Intraocular Lens 250 (clear), +25.50DRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547480480893), received between Apr 26, 2019 and Jul 31, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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
- Material Split, Cut or Torn2
- Break1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. DAMAGED HAPTIC AFTER IMPLANTATION, PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. THE DOCTOR WILL SCHEDULE SECONDARY SURGERY FOR EXPLANTATION. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22683345 ↗InjuryMay 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE; DAMAGED HAPTIC; STICKING HAPTIC. PATIENT HEALTH NOT IMPACTED; SECONDARY SURGERY REQUIRED ON FUTURE DATE. IOL WAS EXPLANTED ON (B)(6) 2024 PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 19337981 ↗InjuryApr 26, 2019Break; Break
THE COMPLAINT DESCRIBES: "THE INJECTED LENS, IT LOOKED OK IN INJECTOR. WHEN IT CAME OUT IT EMERGED THAT SECOND HAPTIC WAS BENT OVER AND UNUSUALLY ACUTE ANGLE. FURTHER INSPECTION SHOWED THAT THE BLUE TIP WAS ONLY ATTACHED BY THE STRAND, ALMOST FULLY OFF. LOOSE END WAS REMOVED, IOL STABLE WITH REMAINING PART OF HAPTIC". CLARIFICATION OF EXPLANT DATE: THE EXPLANT DATE IS RELATED TO THE EXPLANTED "LOOSE END WAS REMOVED". THE IOL STAYS IN THE EYE WITH THE REMAINING PART OF THE HAPTIC.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8558564 ↗
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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