BEUDAMED
    FDA Adverse Event Other Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS.

    MDR report key: 594939 · Received November 29, 2001

    Report

    Report Number
    2023826-2004-01800
    Event Type
    Other
    Date Received
    November 29, 2001
    Date of Event
    November 27, 2001
    Report Date
    November 29, 2001
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A COLLAMER LENS MODEL CC4204BF AND WAS REMOVED SINCE THE PATIENT HAD WEAK EYE MUSCLES. THE MD DECIDED TO REMOVE THE LENS DUE TO THE UNSTABLE CAPSULE. THE FACILITY STATED THERE WAS NO PATIENT INJURY OR A PRODUCT MALFUNCTION. THE MODEL AND LOT NUMBERS OF THE CARTRIDGE AND INJECTOR ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54411 UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS. INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other