BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE

    MDR report key: 1053008 · Received May 22, 2008

    Report

    Report Number
    2023826-2008-00706
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 24, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT A HAPTIC PLATE WAS TORN OFF AND MISSING AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED CC4204BF COLLAMER PLATE LENS AND A HAPTIC WAS TORN OFF UPON INSERTION. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS DUE TO A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL SFC-25| INJECTOR MODEL INDIGO-P| FTP INDIGIO MODEL