BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIC LENS

    MDR report key: 594673 · Received February 21, 2001

    Report

    Report Number
    2023826-2004-01864
    Event Type
    Injury
    Date Received
    February 21, 2001
    Date of Event
    October 16, 2000
    Report Date
    February 21, 2001
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A AA4203VF PLATE SILICONE LENS. IN 01/2001 PATIENT DEVELOPED MILD CIRCUMCORNEAL CONGESTION WITH FRESH NON PIGMENTED KPS, FLARES AND CELLS. PATIENT WAS DIAGNOSED TO PSENDOPHAKIE INTRAOCULAR INFLAMMATION, IRIDOCYCLITIS AND STERILE UVEITIS MD FELT THE REACTION WAS DUE TO THE IOL MATERIAL (SILICONE). BCVA WAS 20/40 (6/12) WITH POST-OP REFRACTION OF +0.50 -2.50 X90. THE LENS REMAINS IMPLANTED. THE IOL INJECTOR, MODEL AND LOT # UNKNOWN. THE IOL INJECTION CARTRIDGE, MODEL AND LOT # UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7255 ELASTIC LENS INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R