BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 3760871 · Received April 4, 2014

    Report

    Report Number
    1119421-2014-00232
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 5, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED. THE PLUNGER HAS BEEN FULLY ADVANCED. NO DAMAGE IS OBSERVED. THE LENS REMAINS IMPLANTED. PRODUCT HISTORY RECORDS REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE CUSTOMER INDICATED THE USE OF AN UNAPPROVED VISCOELASTIC IN THE DEVICE. THE ROOT CAUSE MAY BE RELATED TO A FAILURE TO FOLLOW THE DFU. NO DAMAGE WAS OBSERVED TO THE DEVICE. THE USE OF AN UNQUALIFIED VISCOELASTIC MAY CONTRIBUTE TO UNDERFILL, OVERFILL, MISFOLDING OF THE TRAILING HAPTIC, LACK OF LUBRICITY OR OTHER UNPREDICTABLE OUTCOMES, WHICH MAY RESULT IN LENS DAMAGE OR DELIVERY ISSUES. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. THE SURGEON WAS UNWILLING TO PROVIDE FURTHER INFO. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OF THE DEVICE WAS VERY HARD TO ADVANCE. THE SURGEON REPORTED THAT HE PUSHED THE PLUNGER WITH BOTH HANDS AND THE IOL "POPPED OUT" AND TORE THE ANTERIOR CAPSULAR RIM. THE SURGEON REPORTED THE USE OF AN UNAPPROVED OCULAR VISCOELASTIC DEVICE. THE SURGERY WAS COMPLETED W/O ANY OTHER CONCERNS. THE SURGEON WAS UNWILLING TO PROVIDE FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203737 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD. / HUNTINGTON NA 12262904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HEALON