iSert Intraocular Lens 251 (yellow), +19.00DRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547480450278), received between Mar 25, 2016 and Feb 16, 2021 — classified as 2 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
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Crack1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 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 11335680 ↗MalfunctionSep 12, 2016Crack
REPORT STATED THAT THE SURGEON HAD TO ENLARGE THE INCISION TO 2.5MM FOR REMOVAL OF LENS DUE TO CRACKED HAPTIC DURING INSERTION. THIS EVENT OCCURRED DURING IOL INSERTION. THE PATIENT'S PROGNOSIS WAS REPORTED AS "RECOVERED." CUSTOMER REPORTS THE MALFUNCTION AS A "CRACKED HAPTIC."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5943907 ↗InjuryMar 25, 2016Adverse Event Without Identified Device or Use Problem
REPORT STATED THAT THE LENS HAD TO BE REMOVED AFTER IMPLANT, WIDENING EXCISION AND ANOTHER LENS PLACED IN EYE. AN ANTERIOR VITRECTOMY WAS PERFORMED DUE TO THE PATIENT'S CAPSULE FAILURE. THE DOCTOR INITIALLY INSERTED A HOYA 251 LENS AND HAD TO REMOVE IT BECAUSE THE PATIENT'S CAPSULE FAILED. IT WAS REPLACED WITH A 231 LENS. PATIENT PROGNOSIS WAS REPORTED AS GOOD.
Patient problems: No Code Available
MAUDE report 5526708 ↗
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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