BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 3022936 · Received March 20, 2013

    Report

    Report Number
    2023826-2013-00217
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 21, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PLATE HAPTIC TORN. LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS IN THE PT'S EYE. THE LENS TORE IN THE INJECTOR AS THE SURGEON ATTEMPTED TO INSERT IT. THERE WAS NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115353 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRACOCULAR LENS HQL STAAR SURGICAL CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CARTRIDGE: MODEL NANOPINT, LOT # - UNK| INJECTOR: MODEL NANOPOINT, LOT # - UNK