iSert Intraocular Lens 250 (clear), +13.00DRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547480480640), received between Dec 29, 2015 and Dec 6, 2016 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
- Out-Of-Box Failure1
- Positioning Problem1
Patient problems
- Excessive Tear Production1
- Eye Injury1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2016Material Integrity Problem; Positioning Problem
REPORT STATED AFTER IOL WAS INSERTED INTO THE EYE, WHEN SURGEON WAS "DIALING" IT INTO PLACE, A ROUGH EDGE ON THE IOL CAUSED A TEAR IN POSTERIOR CAPSULE. THE LENS WAS CENTERED IN CAPSULE WHEN PATIENT LEFT THE O.R. THE LENS MAY NEED TO BE EXPLANTED IN THE FUTURE IF IT DOES NOT STAY IN PLACE. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 11, 2016 INDICATED THAT THE LENS WAS EXPLANTED ON (B)(6) 2016 AND WAS REPLACED WITH ANOTHER IOL (AR-40).
Patient problems: Excessive Tear Production; Eye Injury
MAUDE report 6149220 ↗InjuryDec 29, 2015Out-Of-Box Failure
THIS ISSUE WAS REPORTED BY PHYSICIAN AS "THE LENS ARRIVED DAMAGED AND THE OPTIC HAD WHAT LOOKED LIKE SHARK BITES ON IT." THIS ISSUE ON THE OPTIC WAS NOTED DURING THE IMPLANT PROCEDURE. THE IOL NEEDED TO BE REMOVED FROM THE PATIENT'S EYE, AND INCISION ENLARGED IN ORDER TO EXPLANT THE LENS.
Patient problems: No Code Available
MAUDE report 5332967 ↗
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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