BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEE H10

    MDR report key: 614624 · Received June 17, 2005

    Report

    Report Number
    2023826-2005-00781
    Event Type
    Other
    Date Received
    June 17, 2005
    Date of Event
    May 16, 2005
    Report Date
    June 14, 2005
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONTACT STATED THAT THE SURGEON IMPLANTED A CC4204BF PLATE COLLAMER LENS. THE PATIENT'S CHAMBER WOULDN'T HOLD THE LENS, SO THE SURGEON OPTED TO USE A DIFFERENT LENS MODEL. THE LENS WAS REMOVED WITHOUT ENLARGING THE INCISION. NO PATIENT INJURY. THE CARTRIDGE MODEL THAT WAS USED WAS AN SFC-25 FP. THE CONTACT WAS UNABLE TO PROVIDE THE INJECTOR MODEL OR THE INJECTOR AND CARTRIDGE LOT NUMBERS. THIS WAS THE FIRST OF TWO LENSES THAT WERE USED FOR THE SAME PATIENT.

    Description of Event or Problem · 1

    THIS LENS WAS ORIGINALLY REPORTED AS BEING IMPLANTED AND REMOVED, WAS RETURNED IN A SEALED VIAL AS IT WAS NEVER OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other