BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON POSTERIOR CHAMBER INTRAOCULAR LENS

    MDR report key: 3732 · Received July 10, 1992

    Report

    Report Number
    3732
    Event Type
    Malfunction
    Date Received
    July 10, 1992
    Date of Event
    April 28, 1992
    Report Date
    April 30, 1992
    Manufacturer
    ALCON SURGICAL INC
    Product Code
    HQH
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AFTER IMPLANTING IOL IN PATIENTS LEFT EYE, SURGEON NOTICED HAPTI{ TO BE FRACTURED. SURGEON REMOVED IOL AFTER IT HAD BEEN INSERTED WITHOUT ANY PROBLEM. A NEW IOL WAS THEN INSERTED. NO APPARENT INJURY TO THE PATIENT WAS NOTED BY THE SURGEON.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS DESTROYED/DISPOSED OF.

    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 MZ20BD 243643

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other