BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 270913 · Received March 23, 2000

    Report

    Report Number
    1119421-2000-00270
    Event Type
    Other
    Date Received
    March 23, 2000
    Report Date
    February 22, 2000
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED TO REPORT ALLERGY TYPE SYMPTOMS (HIVES, SWELLING IN BOTH EYES, ITCHY EYE LIDS) THAT HAVE DEVELOPED FOLLOWING CATARACT SURGERY. THE RELATIONSHIP BETWEEN THE REPORTED SYMPTOMS AND THE INTRAOCULAR LENS IS NOT KNOWN. MORE INFO IS BEING SOUGHT FROM THE IMPLANTING SURGEON.

    Description of Event or Problem · 1

    ADD'L INFO PROVIDED BY THE IMPLANTING SURGEON INDICATES THAT A POSSIBLE CAUSE FOR THE PT'S REPORTED PERIORBITAL SWELLING HAS NOT BEEN IDENTIFIED. THE PT HAS BEEN REFERRED TO AN OCULOPLASTICS SURGEON TO DETERMINE IF THE SYMPTOMS MAY BE RELATED TO PROLAPSED FAT THROUGH THE ORBITAL SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES MA60BM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention