BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 813953 · Received November 17, 2004

    Report

    Report Number
    2023826-2004-01942
    Event Type
    Malfunction
    Date Received
    November 17, 2004
    Date of Event
    October 18, 2004
    Report Date
    October 18, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULTS - (OTHER): THERE WAS NO LENS IN THE BOX. HOWEVER, THE VISUAL INSPECTION OF CARTRIDGE SFC-25 FP, LOT NUMBER 1190485, SHOWED EVIDENCE OF SURGICAL RESIDUE AND NO VISIBLE DAMAGE.

    Description of Event or Problem · 1

    THE MD ATTEMPTED TO IMPLANT A COLLAMER LENS WITH MODEL CC4204BF. THE FACILITY STATED THAT THE SFC-25 FP CARTRIDGE WITH LOT # 1190485 FELT VERY TIGHT. THE LENS THEN JAMMED INSIDE THE CARTRIDGE AS IT WAS BEING ADVANCED, PRIOR TO IMPLANTATION. THE LENS WAS NOT IMPLANTED AND THERE WAS NO PT INJURY. THE FACILITY BELIEVES THAT THERE WAS A PROBLEM WITH THE CARTRIDGE. AN MSI-PF INJECTOR WAS USED AND THE LOT NUMBER WAS NOT PROVIDED BY THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR