BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1061039 · Received June 13, 2008

    Report

    Report Number
    2023826-2008-00819
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 16, 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
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT A HAPTIC PLATE WAS TORN OFF FROM THE OPTIC AND MISSING, AND THERE WAS A CLEAR SURGICAL RESIDUE ON LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A CC4204BF COLLAMER PLATE LENS AND A HAPTIC BROKE DURING INSERTION. THE LENS WAS REMOVED WITHOUT ANY PT INJURY. THE REPORTER STATED THE INCIDENT WAS DUE TO LOADING ERROR.

    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 57 YR FTP FOAM TIP PLUNGER MODEL| CARTRIDGE MODEL SFC-24 FP| INJECTOR MODEL INDIGO-P