BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 11324356 · Received February 12, 2021

    Report

    Report Number
    3006695864-2021-07181
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 13, 2021
    Report Date
    March 12, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D1 - BRAND NAME - IT WAS INADVERTENTLY SEND BLANK IN THE INITIAL REPORT. THE D9 - RETURNED TO MANUFACTURER - IT WAS INITIALLY REPORTED DEVICE WAS RETURNED TO MANUFACTURER AND A DATE WAS PROVIDED HOWEVER, THIS IS INCORRECT AS THIS IS A LARGE SYSTEM THAT REMAINS AT THE CUSTOMER SITE. E1 - ADDRESS - LINE 1 AND CITY - IN THE INITIAL REPORT THE ADDRESS AND THE CITY WAS NOT INCLUDED. ADDRESS IS (B)(6) AND CITY IS (B)(6).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    TELEPHONE: (B)(6). THIS REPORT IS BEING FILED ON 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. A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT SHOWS NO FAILURE DETECTED. A DOCUMENT LABELING, TRENDING AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WERE PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. AMO¿S 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED ISSUES WITH CATALYS-I. SUCTION LOST DURING LAST SURGERY SESSION. PATIENT INVOLVEMENT, NO PATIENT TREATMENTS DELAYED OR CANCELLED. THROUGH FOLLOW-UP WE HAVE LEARNT THAT THE CUSTOMER DID NOT SAVE THE LOI (LIQUID OPTICS INTERFACE) NEITHER THE LOT NUMBER; ACCORDING TO THE CUSTOMER, THE SURGERY COULD FINISH ON THE SAME DAY AND WITHOUT ANY OTHER PROBLEM. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219643 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1