BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 3770864 · Received December 19, 2013

    Report

    Report Number
    1119421-2013-01239
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED. THE PLUNGER HAS BEEN FULLY ADVANCED. NO DAMAGE IS OBSERVED. THE LENS WAS NOT RETURNED. THE APPROVED VISCOELASTIC WAS INDICATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED BY THE PRODUCT EVALUATION. NO DAMAGE OR ABNORMALITIES WERE OBSERVED. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HE FELT RESISTANCE WHEN TRYING TO ADVANCE THE LENS THROUGH THE INJECTOR. HE CONTINUED TO APPLY PRESSURE CAUSING THE LENS TO SHOOT OUT OF THE INJECTOR. THE IOL TORE THE POSTERIOR CAPSULAR WALL. HE WAS ABLE TO RETRIEVE THE LENS AND SUCCESSFULLY IMPLANTED AN ALTERNATE LENS INTO THE SULCUS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667483 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD. / HUNTINGTON NA 12008847

    Patients

    Seq Age Sex Outcome Treatment
    1 Other VISCOAT