BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2423110 · Received January 18, 2012

    Report

    Report Number
    2023826-2012-00046
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 22, 2011
    Report Date
    December 22, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN AA4203TL TORIC OPTIC SILICONE SINGLE PIECE LENS IN PT'S RIGHT EYE. STATED FIRST DAY PORT-OP, LENS ROTATED 90 DEGREES OUT OF POSITION AND WOULD NOT REMAIN WITH CORRECT AXIS EVEN AFTER REPOSITIONING. LENS NOT BIG ENOUGH OF THIS PT'S CAPSULAR BAG. LENS WAS EXPLANTED AND REPALCED WITH A COMPETITOR'S LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CARTRIDGE: MODEL AND LOT NUMBERS UNK| INJECTOR: MODEL AND LOT NUMMBERS UNK