BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLER-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1945269 · Received December 21, 2010

    Report

    Report Number
    2023826-2010-01287
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 10, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS WAS TORN WHILE LOADING, BUT WAS NOT NOTICED UNTIL THE LENS WAS INSERTED INTO THE PT'S EYE. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES.

    Devices

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

    Patients

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