BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 12170321 · Received July 14, 2021

    Report

    Report Number
    3006695864-2021-08096
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 14, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. (B)(6). DEVICE EVALUATION: THE PRODUCT EVALUATION WAS PERFORMED DURING FIELD SERVICE. THE REPORTED COMPLAINT WAS CONFIRMED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING FIELD SERVICE THAT PUMP FIBER WAS BURNT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063815 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1