BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 11296471 · Received February 8, 2021

    Report

    Report Number
    3006695864-2021-07152
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 12, 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

    CORRECTED DATA: IN REVIEW OF SECTION E IN FOLLOW-UP 1 AND FOLLOW-UP 2, THE COUNTRY WAS INADVERTENTLY SELECTED AS UNITED STATES, HOWEVER, THE COUNTRY SHOULD HAVE BEEN CANADA. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AS INITIALLY REPORTED, ATTEMPTS WERE MADE TO GET CLARIFICATION REGARDING THE EVENT TO NO AVAIL. ON FEBRUARY 9, 2021 THE CUSTOMER REPORTED THAT THE EVENT OCCURRED PRIOR TO LASER FIRING AND NOT WHILE THE LASER WAS FIRING. THIS IS NO LONGER A REPORTABLE MALFUNCTION AND THEREFORE, NO ADDITIONAL INFORMATION WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: G4: IT WAS INITIALLY REPORTED THAT THIS DEVICE PRE-MARKET NOTIFICATION NUMBER WAS K113479 HOWEVER, THE REPORT WAS BEING FILED FOR AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-I, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K200056.

    Additional Manufacturer Narrative · 1

    (B)(6). JOHNSON & JOHNSON INVESTIGATION SUBSEQUENTLY IDENTIFIED THAT THE CATALYS SYSTEM MAY HAVE A REMOTE POTENTIAL EVENT WHERE LOSS OF SUCTION DURING LASER FIRING COULD CREATE A HAZARDOUS SITUATION THAT MAY RESULT IN SCORING OF THE POSTERIOR CORNEAL SURFACE. THEREFORE JOHNSON & JOHNSON SURGICAL VISION, INC HAS ISSUED AN ADVISORY NOTICE TO REINFORCE INSTRUCTIONS PROVIDED IN PRODUCT TRAINING AND IN THE OPERATOR¿S MANUAL REGARDING SUCTION LOSS DURING A PROCEDURE. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT THERE WAS SUCTION LOSS. IT IS NOT CLEAR THAT THE SUCTION LOSS OCCURRED WHILE LASER WAS FIRING. ATTEMPTS TO GET CLARIFY THE EVENT FROM THE REPORTER WERE DONE TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194689 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1