BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE

    MDR report key: 728086 · Received June 21, 2006

    Report

    Report Number
    2023826-2006-00834
    Event Type
    Injury
    Date Received
    June 21, 2006
    Date of Event
    May 23, 2006
    Report Date
    May 23, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: EVALUATION CODE: A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS A PORTION OF THE LENS OPTIC IS TORN OFF AND THE OTHER HAPTIC IS BROKEN. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE CARTRIDGE AND INJECTOR WERE NOT RETURNED FOR EVALUATION. PMA#P990013.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A THREE PIECE LENS MODEL CQ2015 INTO PATIENT'S EYE AND THE HAPTIC TORE OFF. THE PAITENT HAS A PRE-EXISTING DISEASE OF DIABETES WHICH CAUSED THE PATIENT'S INTRAOCULAR PRESSURE TO RISE AND THEIR IRIS TO PROLAPSED INTO THE EYE. THE SURGEON HAD TO ENLARGE THE INCISION TO REMOVE THE LENS AND PERFORMED A POSTERIOR VITRECTOMY TO RELIEVE THE PRESSURE AND PLACED A COMPETETORS LENS IN THE SULCUS. A SUTURE WAS USED TO CLOSE THE WOULD. THE REPORTED STATED THAT THE CAUSE OF THE LEND DAMAGE WAS DUE TO USING THE INCORRECT CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention