BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2070108 · Received April 22, 2011

    Report

    Report Number
    1119421-2011-00463
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 24, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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 DETERMINED. THE PRODUCT WAS NOT RETURNED. HOWEVER, DUE TO INFO PROVIDED, THE EVENT MAY HAVE OCCURRED DUE TO A FAILURE TO FOLLOW THE DFU. CUSTOMER USED 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. EXAMPLE OF POTENTIAL ISSUES CAN BE DUE TO THE LACK OF PROPER ADVANCEMENT OF THE LENS WITH INCORRECT VISCOELASTIC. PER THE DFU, ONE SHOULD GENTLY ADVANCE THE PLUNGER FORWARD IN ONE SMOOTH, CONTINUOUS MOTION UNTIL THE FRONT EDGE OF THE OPTIC ALIGNS WITH THE "FILL-TO" LINE. IT SHOULD REQUIRE SEVEN SECONDS. AFTER CONFIRMING THE LENS POSITION (AT THIS POINT DEPLOYMENT SHOULD NOT PROCEED IF THE LENS IS NOT IN AN APPROVED POSITION) INSERT NOZZLE TIP INTO INCISION. GENTLY ADVANCE THE PLUNGER IN ONE SMOOTH, CONTINUOUS MOTION. IT IS RECOMMENDED THAT THE DELIVERY OF THE LENS FROM THE VISUAL INSPECTION POSITION TAKE AT LEAST FIVE SECONDS. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. 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 INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON STATED WHEN THE IOL WAS EJECTED FROM THE DELIVERY SYSTEM, IT WAS NOT WELL CONTROLLED. AS A RESULT, A POSTERIOR CAPSULAR TEAR OCCURRED. ADDITIONAL INFO WAS RECEIVED IN A F/U PHONE CALL WITH AN OPERATING ROOM NURSE WHO REPORTED AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE IOL WAS REMOVED AND REPLACED. SINCE THIS EVENT, THE SURGEONS OF THE FACILITY HAVE CHANGED THE WAY THEY WORK. WITHOUT BEING IN CONTACT WITH THE PT'S EYE, THE PLUNGER IS FULLY ADVANCED, AND THEN THE IOL IS PLACED INTO A CARTRIDGE AND IMPLANTED. THE NURSE REPORTED, THE USE OF AN UNAPPROVED VISCOELASTIC. AS A CLINICAL CONSEQUENCE, THE SURGEON MENTIONED A FUNCTIONAL LOSS OF AN ORGAN (VISION) AND AN INCREASED RISK OF INFECTION. ADDITIONAL INFO 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 11052981

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROVISC