BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 312815 · Received January 17, 2001

    Report

    Report Number
    1119421-2001-00058
    Event Type
    Injury
    Date Received
    January 17, 2001
    Date of Event
    December 14, 2000
    Report Date
    December 18, 2000
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE NURSE PROVIDED ADDITIONAL INFORMATION STATING THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) ONE HAPTIC BROKE. THE SURGEON WIDENED THE WOUND TO REMOVE THE BROKEN LENS AND INSERTED A DIFFERENT IOL. THE EYE WAS PATCHED FOR 24 FOUR FOLLOWING SURGERY.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THE WOUND HAD TO BE WIDENED TO ALLOW REMOVAL OF AN INTRAOCULAR LENS IMMEDIATELY AFTER PLACEMENT. MORE INFO IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON MA30BA 599919

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention