BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 3040092 · Received April 3, 2013

    Report

    Report Number
    1119421-2013-00345
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE 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. THE PRODUCT WAS USED WITHOUT PROPER INSTRUCTION. COMPANY GUIDELINES REQUIRE SURGEONS TO BE TRAINED AND A SIGNED CERTIFICATE PROVIDED TO ALCON BEFORE THE PRE-LOADED IOL CAN BE ORDERED/USED. ELEVEN PRE-LOADED IOLS WERE SHIPPED TO THE CLINIC INSTEAD OF SINGLE LENSES. THE SHIPMENT WAS SENT WITHOUT PRIOR TRAINING OF THE SURGEON. THIS WAS THE FIRST TIME THE SURGEON HAD EVER USED THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CAPSULAR RUPTURE OCCURRED WHEN THE LENS WAS BEING INJECTED INTO THE EYE. A VITRECTOMY WAS PERFORMED AND ANOTHER IOL WAS PLACED IN THE SULCUS. THE SURGEON STATED THE CAPSULE RUPTURE WAS CAUSED BY THE PISTON OF IOL INJECTOR. THIS WAS THE FIRST TIME THAT THE SURGEON IMPLANTED THIS TYPE OF IOL, SO SHE WAS NOT TRAINED TO USE IT. THE IOL WAS ORDERED IN ERROR, DUE TO A MISTAKE IN THE ORDER INTAKE INFO. IN A FOLLOW UP, THE SURGEON REPORTED THAT ALTHOUGH THE PT WAS DOING FINE AT DAY ONE FOLLOWING SURGERY, HE PRESENTED WITH INDUCED ASTIGMATISM DUE TO THE IOL BEING EXCHANGED AND PLACED IN THE SULCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135936 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD./HUNTINGTON NA 12166019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention