BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 726521 · Received June 15, 2006

    Report

    Report Number
    2023826-2006-00782
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    May 18, 2006
    Report Date
    May 18, 2006
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    p990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS ONE PLATE HAPTIC IS TORN OFF & MISSING. CLEAR SURGICAL RESIDUE ON THE LENS. NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY AND EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. PMA# IS P990013.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A SINGLE PIECE COLLAMER LENS MODEL CC4204BF INTO PT'S EYE AND THE LENS TORE. THE SURGEON REMOVED AND REPLACED THE LENS WITH ANOTHER MODEL LENS WITHOUT ENLARGING THE INCISION. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC INTRAOCULAR LENS HQL STAAR SURGICAL CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CARTRIDGE MODEL:SFC-45 FP LOT#: UNK,| INJECTOR MODEL:MSI-TF, LOT#: UNK| VISCOELASTIC MODEL: STAARVISC II.LOT#:UNK.