BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIBA VISION MEMORY LENS

    MDR report key: 459328 · Received May 13, 2003

    Report

    Report Number
    2648694-2003-00048
    Event Type
    Injury
    Date Received
    May 13, 2003
    Date of Event
    March 4, 2003
    Report Date
    April 14, 2003
    Manufacturer
    CIBA VISION CORP.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT AN OPACIFIED MEMORY LENS WAS EXPLANTED AND REPLACED IN PT'S LEFT EYE IN 2003. 20 DAYS LATER SURGERY WAS PERFORMED TO RELIEVE PRESSURE (BLEB) DUE TO HIGH IOP FOLLOWING EXPLANT/REPLACEMENT PROCEDURE. AT FOLLOW UP VISIT 1 WEEK LATER, METHYLPREDNISONE PRESCRIBED. NO FURTHER COMPLICATIONS REPORTED. SEVERAL REQUESTS FOR ADDITIONAL INFO HAVE BEEN MADE. NO FURTHER INFO IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIBA VISION MEMORY LENS INTRAOCULAR LENS HQL CIBA VISION CORP. U940A *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other NONE REPORTED