BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLI IOL DELIVERY SYSTEM

    MDR report key: 24004473 · Received January 8, 2026

    Report

    Report Number
    1000635309-2026-00001
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    September 30, 2025
    Report Date
    January 8, 2026
    Manufacturer
    AST PRODUCTS, INC.
    Product Code
    MSS
    UDI-DI
    10814899027164
    PMA / PMN Number
    K200057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR FOR DEVICE INVOLVED WAS REVIEWED AND NO ABNORMALITIES WERE FOUND; THE INSPECTION RESULTS WERE FOUND TO BE QUALIFIED. THE DEVICE INVOLVED IN THE CLAIM WAS NOT RETURNED. TESTING WAS CONDUCTED USING A RENTENTION SAMPLE TAKEN FROM THE SAME LOT REFERENCED IN THE CLAIM. A LENS WAS LOADED INTO THE RETENTION SAMPLE AND DELIVERY WAS SUCCESSFUL. NO PHENOMENA SIMILAR TO THE FEEDBACK RECEIVED FROM THE CUSTOMER WAS OBSERVED DURING TESTING. ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED THAT THE BIOLI IOL DELIVERY SYSTEM, MODEL BIOLI-A1, WAS USED TO IMPLANT THE CUSTOMER'S IC-8 INTRAOCULAR LENS INTO PATIENT'S RIGHT EYE ON (B)(6) 2025. THE IOL OPTIC WAS FOUND TO BE "NOT CLEAR" AND "CENTRAL POSTERIOR STREAKS" WERE OBSERVED BY THE SURGEON UPON SLIT LAMP EXAMINATION ON THE ORIGINAL DATE OF SURGERY. THE PATIENT REPORTED SEEING "PURPLE COLORS WITH TOTAL BLURRED VISION" ONSET 1-DAY POST-OP ON (B)(6) 2025. SECONDARY SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2025 TO EXCHANGE THE LENS AND THE PATIENT OUTCOME WAS REPORTED AS GOOD. THE SURGEON THINKS THE LIKELY CAUSE OF THE DAMAGE WAS POSSIBLE DEFECT OF DELIVERY DEVICE. NO ADDITIONAL SUPPORTING INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67909 BIOLI IOL DELIVERY SYSTEM Folders and injectors, intraocular lens (iol) MSS AST PRODUCTS, INC. BIOLI-A1 FLJ1308 10814899027164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention