BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 11606284 · Received April 1, 2021

    Report

    Report Number
    3006695864-2021-07438
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    October 30, 2020
    Report Date
    April 19, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURE DATE REPORTED WAS INCORRECT. THE CORRECT MANUFACTURE DATE IS 11/10/2014. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY- UNKNOWN, NOT PROVIDED. TELEPHONE NO.- (B)(6). (B)(4). A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR CATALYS-I LASER SYSTEM SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    AN UNSPECIFIED ISSUE AFTER LASER FIRING WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING THE CATALYS LASER PROCEDURE ON (B)(6) 2020, AN ISSUE OCCURRED DURING THE LASER FIRING PORTION OF THE PROCEDURE. PER FOLLOW UP WITH THE ACCOUNT, THE TECHNICIAN AT THE TIME OF THE INCIDENT COULD NOT REMEMBER SPECIFICS. TAKING A CONSERVATIVE APPROACH, THE EVENT IS BEING REPORTED AS SUCTION LOSS AFTER LASER FIRE AS THAT IS THE MOST LIKELY SCENARIO. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503178 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 LIQUID OPTIC INTERFACE, LOT: 14178915