BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1141390 · Received August 20, 2008

    Report

    Report Number
    2023826-2008-01091
    Event Type
    Other
    Date Received
    August 20, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 30, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE MIDDLE OF THE OPTIC 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 A CC4204BF COLLAMER PLATE LENS AND HALF THE LENS REMAINED IN THE INJECTOR UPON INSERTION. THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL LENS 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 INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

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