BEUDAMED
    FDA Adverse Event Other Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS.

    MDR report key: 599232 · Received May 5, 2005

    Report

    Report Number
    2023826-2005-00558
    Event Type
    Other
    Date Received
    May 5, 2005
    Date of Event
    March 17, 2005
    Report Date
    April 7, 2005
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A COLLAMER LENS MODEL CC4204BF AND WAS REMOVED WITHOUT PATIENT INJURY. THE NURSE STATED THE SURGEON HAD MISCALCULATED THE POWER OF THE LENS AND IMPLANTED THE INCORRECT DIOPTER. THE SURGEON RECALCULATED AND IMPLANTED THE PROPER LENS. IT WAS STATED STATED THE INDINGO-P INJECTOR AND SFC-25 CARTRIDGE WERE USED, BUT THE LOT NUMBERS WERE UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other