BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2070129 · Received April 22, 2011

    Report

    Report Number
    1119421-2011-00475
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE, THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO LOT NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. IF THE PLUNGER WAS DIFFICULT TO PUSH, IT COULD BE POTENTIAL TO HESITATE THE ADVANCEMENT OF THE LENS PROPERLY THROUGH THE PLUNGER. 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. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PLUNGER OF THE DELIVERY SYSTEM WAS VERY HARD TO PUSH. THE IOL WAS SUDDENLY EJECTED AND LED TO A CAPSULAR BAG TEAR. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention