BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 7340250 · Received March 14, 2018

    Report

    Report Number
    3005675890-2018-00011
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    February 14, 2018
    Report Date
    April 27, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    OOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCOUNT REPORTED DURING FOLLOW UP THAT THE INCIDENT THAT OCCURRED THAT DAY WITH THAT PATIENT WAS NOT RELATED WITH THE TREATMENT PERFORMED WITH THE CATALYS AND IN ADDITION, IT DID NOT HAVE ANY OTHER CONSEQUENCES. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (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) # K121091. AN 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. MANUFACTURING DATE - 2015. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO 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. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED. MANUFACTURING DATE - MAY 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TREATMENT WITH CATALYS, EPITHELIAL DAMAGE WAS OBSERVED UNDER THE MICROSCOPE. CORNEA HAD IRREGULAR SHAPE THAT DID NOT COINCIDE WITH THE FRAGMENTATION PATTERN OF THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181509 CATALYS SYSTEM CATALYS OOE ABBOTT MEDICAL OPTICS CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention