BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2971458 · Received June 29, 2006

    Report

    Report Number
    2023826-2006-01986
    Event Type
    Malfunction
    Date Received
    June 29, 2006
    Date of Event
    April 26, 2006
    Report Date
    May 30, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT ONE LENS HAPTIC ALONG WITH PART OF THE LENS OPTIC WERE TORN OFF AND MISSING. CLEAR SURGICAL RESIDUE/DEBRIS ON THE PRODUCT. CONCLUSION: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON ATTEMPTED TO INSERT A CQ2015 THREE PIECE COLLAMER LENS AND THE LENS JAMMED IN THE CARTRIDGE. NO PT INJURY. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE USER FACILITY, BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFO IS RECEIVED A SUPPLEMENTAL MEDWATCH SHALL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL MSI-PM, LOT NUMBER UNK| CARTRIDGE: MODEL CQ CARTRIDGE-FP, LOT NUMBER UNK| VISCOCLASTIC, STAAR VISC II, LOT NUMBER UNK