iSert Intraocular Lens 250 (clear), +6.00DRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04547480480503), received between Jul 12, 2022 and Jul 12, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
- Device Appears to Trigger Rejection1
Patient problems
- Uveitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
REPORTED CASE OF INFLAMMATION (B)(6). (B)(6) 2022: MANUFACTURER'S FIRST DATE OF AWARENESS. THE IOL WAS IMPLANTEDON (B)(6) 2022. THE INFLAMMATION WAS NOTED 3 WEEKS LATER. PATIENT WAS TREATED WITH STEROIDS AND ANTIBIOTICS FOR 3 WEEKS RESOLUTION OF INFLAMMATION WAS NOTED ON (B)(6) 2022 (B)(6) 2022: AUTHORIZED COUNTRY REPRESENTATIVE ASSESSED AS A REPORTABLE EVENT TO COFEPRIS BY END OF YEAR.
Patient problems: Uveitis
MAUDE report 14989195 ↗
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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