BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON POSTERIOR CHAMBER INTRAOCULAR LENS

    MDR report key: 3724 · Received July 10, 1992

    Report

    Report Number
    3724
    Event Type
    Malfunction
    Date Received
    July 10, 1992
    Date of Event
    February 25, 1992
    Report Date
    March 30, 1992
    Manufacturer
    ALCON SURGICAL INC
    Product Code
    HQH
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DOCTOR NOTED HAPTIC ON I.O.L WAS CRACKED AFTER IT WAS IMPLANTED IN PATIENTS LEFT EYE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, INVALID DATA. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON POSTERIOR CHAMBER INTRAOCULAR LENS Implant POSTERIOR CHAMBER LENS HQH ALCON SURGICAL INC MZ 60 BD NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other