BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOCULAR LENS IMPLANT

    MDR report key: 23984 · Received March 20, 1995

    Report

    Report Number
    23984
    Event Type
    Injury
    Date Received
    March 20, 1995
    Date of Event
    March 7, 1995
    Report Date
    March 20, 1995
    Manufacturer
    ALCON SURGICAL, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CAME TO THE HOSP FOR OUTPT CATARACT SURGERY WITH LENS IMPLANT. SURGERY WAS SUCCESSFUL AND THE PT WAS DISCHARGED HOME. THE FOLLOWING DAY THE PT WAS READMITTED WITH AN INFECTION IN THE OPERATIVE EYE. PT RECEIVED BOTH SYSTEMIC AND INTRAOCULAR ANTIBIOTIC TREATMENT. PHYSICAN PROGRESS NOTES INDICATE PT MOST LIKELY WILL LOSE THE OPERATIVE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAOCULAR LENS IMPLANT Implant LENS IMPLANT HQL ALCON SURGICAL, INC. ME 60 MD

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention| S