BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2002581 · Received February 4, 2011

    Report

    Report Number
    2023826-2011-00096
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    February 26, 2010
    Report Date
    January 5, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (OTHER): NO LENS IN RETURNED PACKAGING. EVALUATION: CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): THE PRODUCT PERTAINING TO THIS CLAIM WAS NOT RETURNED FOR EVAL. BASED ON THE COMPLAINT HISTORY, IT WAS DETERMINED THAT A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS WAS USED. LENS WAS TORN. FURTHER INFO HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFO IS AVAILABLE.

    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 75 YR