BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 810162 · Received October 12, 2006

    Report

    Report Number
    2023826-2006-01506
    Event Type
    Malfunction
    Date Received
    October 12, 2006
    Report Date
    September 14, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A WORK ORDER SEARCH WAS PERFORMED FOR THE LENS. VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT ONE LENS HAPTIC IS PARTIALLY TORN OFF AND MISSING. CLEAR SURGICAL AND REDDISH RESIDUE/DEBRIS ON THE PRODUCT. AN EMPTY MTC-60C FP CARTRIDGE TRAY WAS RETURNED WITH LOT # 1182247. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SEARCH. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT WHEN THE AA4203TL SINGLE PIECE SILICONE LENS STERILE POUCH WAS OPENED, IT WAS NOTICED THAT THE LENS HAPTIC WAS BROKEN. NO PT CONTACT OR INJURY.

    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 YR CARTRIDGE MODEL MTC-60C, LOT NUMBER 1182247.