BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON PHACOEMULSIFICATION HANDPIECE

    MDR report key: 4134 · Received February 8, 1993

    Report

    Report Number
    4134
    Event Type
    Injury
    Date Received
    February 8, 1993
    Date of Event
    November 6, 1992
    Manufacturer
    ALCON MANUFACTURING
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LEFT EYE EXTRACAPSULAR CATARACT EXTRACTION BY PHACOEMULSIFICATION ON 6/1/92. EYE CHECKED IN OFFICE ON 6/18/92 AND WAS CLEAR AT THAT TIME. EYE CHECKED IN OFFICE ON 8/7/92 AND FOUND A SMALL FOREIGN BODY ON IRIS. REPORTED TO HOSPITAL IN 9/92.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON PHACOEMULSIFICATION HANDPIECE PHACOEMULSIFICATION HANDPIECE HQC ALCON MANUFACTURING UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention