iSert Intraocular Lens 251 (yellow), +17.50DRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547480450247), received between Apr 26, 2019 and Feb 16, 2021 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Crack1
- Delivered as Unsterile Product1
- Material Split, Cut or Torn1
Patient problems
- No Information2
- No Known Impact Or Consequence To Patient1
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IMPLANT DATE: (B)(6) 2020. FLAWED OPTIC: OPTIC SURFACE REFLECTION; PATIENT SEES THE HALO EFFECT ON THE PERIPHERY OF THE OPTIC. POST-OPERATIVE COMPLICATIONS; WITHIN 5 DAYS AFTER IMPLANTATION, NO INFLAMMATION. LENS REMAINS IMPLANTED.
Patient problems: Visual Disturbances
MAUDE report 11335670 ↗MalfunctionSep 9, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
THE OUTER PACKAGE OF THIS PRODUCT WAS IN UNDAMAGED CONDITION, BUT THE INNER PACKAGE (POUCH) WAS BROKEN AND HAD BEEN EXPOSED TO AIR, UNABLE TO GUARANTEE THE QUALITY OF STERILIZATION, IMPLANTING EYES MAY CAUSE EYE INFECTIONS, COULD ENDANGER THE HEALTH OF PATIENT. THE OPERATION WAS POSTPONED TO THE NEXT DAY. EVENT OCCURRED IN (B)(6). THERE WAS NO IMPACT TO PATIENT, BUT IT WAS REPORTED BY HOSPITAL AS AE TO (B)(6) AUTHORITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8976722 ↗InjuryApr 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
ON INSERTION OF LENS, CONSULTANT NOTED THAT THE BLUE HAPTIC WAS DETACHED AND REMAINED BEHIND THE LENS CARTRIDGE. INSERTED LENS WAS CUT IN HALF IN ORDER TO REMOVE, AND A REPLACEMENT LENS REINSERTED.
Patient problems: No Information
MAUDE report 8558417 ↗InjuryApr 26, 2019Crack; Crack
WHEN THE LENS WAS INSERTED IN TO THE EYE, A PIECE OF THE OPTIC WAS MISSING FROM THE OUTSIDE EDGE. THE LENS HAD TO BE CUT IN HALF AND REMOVED, AND ANOTHER WAS THEN INSERTED.
Patient problems: No Information
MAUDE report 8558404 ↗
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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