BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 399598 · Received June 13, 2002

    Report

    Report Number
    1119421-2002-00227
    Event Type
    Injury
    Date Received
    June 13, 2002
    Date of Event
    April 29, 2002
    Report Date
    May 13, 2002
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE HAPTICS CAME OFF. THE SURGICAL INCISION WAS ENLARGED TO FACILITATE REMOVAL OF THE DAMAGED IOL. DURING THE PROCEDURE, THE CAPSULAR BAG TORE AND AN ANTERIOR VITRECTOMY WAS REQUIRED. AN ANTERIOR CHAMBER LENS WAS THEN IMPLANTED. ON POSTOP DAY ONE, RELEASE OF INTRAOCULAR FLUID THROUGH THE PARACENTESIS WAS REQUIRED DUE TO INCREASED INTRAOCULAR PRESSURE. THE PATIENT'S VISUAL ACUITY (VA) PRIOR TO PROCEDURE ON 03/2002 WAS 20/30. VA ON 05/2002 WAS 20/80 P.H. 20/60. THE SURGEON STATED THE PATIENT'S VISION CONTINUES TO IMPROVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON MA60AC 677507

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention