BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 726200 · Received June 8, 2006

    Report

    Report Number
    2023826-2006-00746
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 3, 2006
    Report Date
    May 12, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULTS-VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF THE LENS OPTIC AND ONE PIECE HAPTICF TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH FOUND NO SIMILAR COMPLAINTS WITHIN THE WORK ORDER. CONCLUSIONS-BASED ON THE COMPLAINT HISTORY, THE WORK ORDER SEARCH AND THE EVALUATION OR THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (510(K)#P880091)

    Description of Event or Problem · 1

    THE TECHNICIAN OPENED THE LENS TRAY OF AN AA4203TL TORIC SILICONE PLATE LENS AND NOTED THAT THE LENS WAS RECEIVED TORN. THE LENS WAS NOT USED AND THERE WAS NO PATIENT CONTACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR