BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2080131 · Received April 7, 2011

    Report

    Report Number
    2023826-2011-00311
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 4, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS. LENS TORE UPON INSERTION INTO THE EYE. LENS WAS REMOVED WITH NO PT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR CARTRIDGE: MODEL NANOPOINT, LOT NUMBER UNK| INJECTOR: MODEL NANOPOINT, LOT NUMBER UNK