BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE

    MDR report key: 731920 · Received June 23, 2006

    Report

    Report Number
    2023826-2006-00865
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: EVALUATION RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, THE WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. PMA P900048.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TECHNICIAN OPENED THE LENS POUCH OF AN AQ2010V SILICONE THREE-PIECE LENS AND NOTED THAT ONE HAPTIC LOOKED BENT. THE HAPTIC DID NOT LOOK RIGHT AND IT WAS DECIDED NOT TO USE THE LENS. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR