BEUDAMED
    FDA Adverse Event Summary report: N

    SUPER VITRECTOMY

    MDR report key: 4801 · Received January 28, 1993

    Report

    Report Number
    4801
    Date Received
    January 28, 1993
    Date of Event
    August 14, 1992
    Report Date
    January 26, 1993
    Manufacturer
    ALCON LABORATORIES
    Product Code
    EYN
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    FILTER IRRIGATION SET FAILED CAUSING PATIENT'S EYE TO BECOME SOFT AND AIR ENTERED EYE RESULTING IN CATARACT FORMATION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER VITRECTOMY FILTER IRRIGATION SET EYN ALCON LABORATORIES SV2055

    Patients

    Seq Age Sex Outcome Treatment
    1 Invalid Data