iSert Intraocular Lens 250 (clear), +25.00DRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547480480886), received between Nov 16, 2016 and Apr 26, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Failure to Eject1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2019Break; Failure to Eject; Break; Failure to Eject
THE SCRUB REPORTED THAT WHEN THE LEADING HAPTIC WENT INTO THE EYE, THE INJECTOR WOULD NOT ADVANCE, IT WAS STUCK. THE SURGEON REMOVED THE LENS FROM THE EYE AND ASKED FOR THE REPLACEMENT. UPON INSPECTION THE TRAILING HAPTIC WAS BROKEN OFF FROM THE LENS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8558511 ↗MalfunctionNov 16, 2016Break
INITIALLY RECEIVED A REPORT STATING THE HAPTIC BROKE DURING EJECTION. SUBSEQUENTLY, THE HAPTIC FOR THE BACKUP LENS ALSO BROKE DURING EJECTION WITH PATIENT CONTACT. NO OTHER INFORMATION WAS AVAILABLE AT THAT TIME. ON NOVEMBER 2, 2016 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE INITIAL IOL WAS REMOVED INTRAOPERATIVELY USING GRASPERS AND AN IOL CUTTER AFTER INCREASING THE SIZE OF INCISION WITH A 15 DEG BLADE. THIS OCCURRED WITHOUT INCIDENT. A SECOND IOL WAS ATTEMPTED TO INSERT BUT WHILE CHECKING THE IOL, IT TOO, HAD A TRUNCATED TRAILING HAPTIC. THIS IOL WAS NOT INSERTED INTO THE EYE. SUBSEQUENTLY AN ALCON IOL WAS INSERTED WITHOUT INCIDENT. THE PATIENT DID WELL AND WAS INFORMED. THERE WERE NO OTHER COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6107726 ↗
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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