BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1622459 · Received February 23, 2010

    Report

    Report Number
    2023826-2010-00178
    Event Type
    Other
    Date Received
    February 23, 2010
    Date of Event
    January 20, 2010
    Report Date
    January 26, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED BOTH A REDDISH AND A DARK SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE SURGEON INSERTED THE CC4204A COLLAMER PLATE LENS, AND THE BAG WAS TOO SMALL TO SUPPORT IT. THE LENS WAS REMOVED WITHOUT ANY PATIENT 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. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR STAARVISC II, LOT #UNK| CARTRIDGE: MODEL SFC-25FP, LOT #UNK| INDIGO FTP MODEL, LOT #UNK| INJECTOR: MODEL INDIGO-P, LOT #UNK