BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1222076 · Received November 6, 2008

    Report

    Report Number
    2023826-2008-01367
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 14, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR, CARTRIDGE AND FOAM TIP PLUNGER WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204BF COLLAMER SINGLE PIECE LENS AND THE LENS TORE. THE INCISION WAS ENLARGED TO REMOVE THE LENS. THE REPORTER STATED THE LENS WAS NOT LOADED CORRECTLY.

    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 CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK