BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2231176 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01043
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. A FAILURE TO FOLLOW THE DFU WAS INDICATED IN THE FILE WITH THE USE OF AN UNAPPROVED VISCOELASTIC. VISCOSITY OF AN UNAPPROVED OVD MAY CONTRIBUTE TO UNDERFILL/OVERFILL, MISFOLDING OF THE TRAILING HAPTIC, LACK OF LUBRICITY OR OTHER UNPREDICTABLE OUTCOMES, WHICH CAN RESULT IN DAMAGE. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. NO FURTHER ACTION IS WARRANTED AT THIS TIME. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THE POSTERIOR CAPSULE RUPTURED DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATED THERE WAS NO VITREOUS LOSS AND THE PATIENT IS DOING FINE. SHE REPORTED THE LENS REMAINS IMPLANTED. AN UNAPPROVED VISCOELASTIC WAS USED WITH THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD. / HUNTINGTON NA 12012147

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other PROVISC