BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2832463 · Received November 14, 2012

    Report

    Report Number
    2023826-2012-00923
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    May 22, 2012
    Report Date
    October 24, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT, TORN MATERIAL. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. THE LENS WAS RETURNED IN LIQUID AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND THE LENS TORE. THE LENS WAS REMOVED AND ANOTHER SAME MODEL LENS WAS IMPLANTED. SUTURES WERE NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK