iSert Intraocular Lens 230 (clear), +20.00DRecalls & 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 04547480301310), received between Feb 19, 2016 and Jun 30, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Appropriate Device Problem Term/Code Not Available2
- Break1
- Detachment Of Device Component1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2021. POST-OPERATIVE COMPLICATION; GLISTENING. IT WAS CONFIRMED THAT THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY; NO YAG OR EXPLANT REQUIRED. LENS REMAINS IMPLANTED IN PATIENTS EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14881424 ↗InjuryApr 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
POST-OPERATIVE COMPLICATIONS. PATIENT COMPLAINED OF BLURRED VISION 3 WEEKS AFTER IMPLANTATION. ORIGINAL IMPLANT DATE WAS (B)(6) 2021. THE ORIGINAL PROCEDURE WAS NOT COMPLICATED IN ANY WAY AND THE ORIENTATION OF THE LENS WAS NOT CHANGED. THE LENS WAS EXCHANGED ON (B)(6) 2021 FOR 18.0 DIOPTER POWER. THE LENS EXCHANGE WAS CAUSED BY THE PATIENT WANTING BETTER DISTANCE VISION. THE OUTCOME IS GOOD. 12-APR-2021: ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: AS NOTED BELOW: THE SURGEON DOES NOT BELIEVE THIS IS DEVICE RELATED. THE IOL EXCHANGE OCCURRED BECAUSE THE PATIENT WANTED BETTER DISTANCE VISION, SO THEY EXPLANTED AND EXCHANGED FOR A DIFFERENT DIOPTER.
Patient problems: Blurred Vision
MAUDE report 11611345 ↗MalfunctionFeb 19, 2016Break; Detachment Of Device Component
DURING IOL INSERTION, THE LEADING HAPTIC BROKE OFF WHILE PLUNGING FORWARD. THE INCISION NEEDED TO BE ENLARGED TO REMOVE THE IOL. NO INJURY AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THE FACILITY DISPOSED OF THE PRODUCT AND WAS UNABLE TO RETURN IT FOR PROPER INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5448488 ↗
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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