BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 229868 · Received June 30, 1999

    Report

    Report Number
    MW1016643
    Event Type
    Malfunction
    Date Received
    June 30, 1999
    Date of Event
    May 1, 1999
    Report Date
    June 14, 1999
    Manufacturer
    MEDICAL DEVELOPMENT RESEARCH, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR ON 6/18/99: AS OF TODAY, MDR, INC HAS NOT RECEIVED INFO CONCERNING THE PTS' PRE-AND POST OPERATIVE STATUS, PHYICIAN'S FINDINGS, OPERATING FACILTIES, ETC. MDR, INC. HAS FAXED A TOTAL OF FIVE URGENT NOTICES TO THE RPTR. MEDICAL DEVELOPMENTAL RESEARCH, INC REVIEW OF DEVICE HISTORY RCORDS, STERILIZATION RECORDS AND LAL TESTING FOR THE INTRAOCULAR LENS LOT NUMBERS LISTED ON THE 5/17 COMPLAINT DO NOT CONTAIN DEVIATIONS FROM STANDARD MFG PRCESS. ALL INTRAOCULAR LENSES RELEASED TO INVENTORY PASSED ALL REQUIRED SPECS. 10X EXAMINATION OF SEALED/STERILE RETAINERS FROM THE INTRAOCULAR LENS LOTS IN QUESTION DEMONSTRATED THE LENSES TO BE CLEAR. A REVIEW OF THE INSTRUCTIONS FOR USE SHEET CLEARLY INDICATES THAT "THE SURGEON MUST BE AWARE OF THE RISK OF OPACIFICATION OF THE INTRAOCULAR LENS, WHICH MAY NECESSITATE LENS REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant IOL HQL MEDICAL DEVELOPMENT RESEARCH, INC. SC60B-OUV 70712130

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other