BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1359977 · Received March 4, 2009

    Report

    Report Number
    2023826-2009-00218
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    January 30, 2009
    Report Date
    February 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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RPTR STATED THE SURGEON INSERTED A CC4204BF COLLAMER SINGLE PIECE LENS AND THE LENS BROKE. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES.

    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 INJECTOR: MODEL UNK| FOAM TIP PLUNGER: MODEL UNK| CARTRIDGE: MODEL UNK