iSert Intraocular Lens 251 (yellow), +23.50DRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547480450360), received between Feb 16, 2021 and Feb 24, 2024 — classified as 3 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Crack1
- Misfocusing1
Patient problems
- Failure of Implant1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2024Misfocusing; Misfocusing
EVENT OCCURRED IN MYANMAR. THE COMPLAINT IS ABOUT THE POWER INSIDE THE IOL AND THE POWER ON THE LABEL ARE NOT THE SAME. AFTER SURGERY THE DISTANCE POWER RESULT IS 5.00 PROBLEM CODE: A0601 - MISFOCUSING.
Patient problems: Visual Impairment
MAUDE report 18774744 ↗InjuryJul 11, 2023Crack; Crack
EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED OPTIC AFTER IMPLANTATION PROBLEM CODE: A0404 CRACK. IMPLANT DATE: (B)(6)2020. EXPLANT DATE: (B)(6)2020. PATIENT IMPACT: DEVICE EXPLANTATION.
Patient problems: Failure of Implant
MAUDE report 17297442 ↗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 11335633 ↗
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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