BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2223734 · Received August 25, 2011

    Report

    Report Number
    2023826-2011-00733
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 4, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, LENS DAMAGED IN DELIVERY SYSTEM. DEVICE EVALUATED BY MANUFACTURER. LENS NOT RETURNED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION:RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND ONE HAPTIC TORN. A PIECE OF THE LENS OPTIC AND THE OTHER HAPTIC WERE TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. (B)(4)

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND THE LENS WAS DAMAGED, THE TAIL END OF THE LENS CRINKLED IN THE INJECTOR. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE LENS DAMAGE WAS DUE TO A LOADING ERROR.

    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 INJECTION SYSTEM MODEL NANOPOINT - LOT NUMBER UNK