BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1032603 · Received April 22, 2008

    Report

    Report Number
    2023826-2008-00573
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    January 8, 2008
    Report Date
    March 28, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204BF COLLAMER SINGLE PIECE LENS BUT THE LENS WOULD NOT CENTER. THERE WAS PT CONTACT BUT NO INJURY. SUTURES WERE NOT REQUIRED. ADD'L INFO HAS BEEN REQUESTED FROM THE FACILITY BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAIL, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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 FOAM TIP PLUNGER MODEL FTP INDIGO-LOT NUMBER UNK| CARTRIDGE MODEL SFC-25 FP LOT NUMBER UNK| INJECTOR MODE INDIGO-P LOT NUMBER UNK