BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1052999 · Received May 27, 2008

    Report

    Report Number
    2023826-2008-00738
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 12, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A CC4204BF COLLAMER SINGLE PIECE LENS DUE TO A SCRATCH ON THE LENS. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE REPORTER STATED THE LENS WAS DAMAGED WHILE BEING INSERTED. ANOTHER SAME TYPE LENS WAS IMPLANTED.

    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 COMPANY CC4204BF NA

    Patients

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