BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1415472 · Received January 29, 2009

    Report

    Report Number
    2023826-2009-00080
    Event Type
    Other
    Date Received
    January 29, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 5, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL- RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT ONLY A PIECE OF THE OPTIC AND HALF OF A HAPTIC PLATE WAS RETURNED. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A CC4204BF COLLAMER PLATE LENS AND THE SURGEON DID NOT LIKE THE WAY THE LENS SEATED IN THE EYE. THE LENS TORE AS THE SURGEON WAS REMOVING IT BUT THERE WAS NO PT INJURY.

    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 CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INJECTOR MODEL: INDIGO-P| FOAM TIP PLUNGER MDOEL| CARTRIDGE MODEL SFC-25 FP