BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 6992074 · Received October 31, 2017

    Report

    Report Number
    3005675890-2017-00068
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    September 30, 2017
    Report Date
    December 2, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    OOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING YEAR 2012. 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. IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT SYSTEM WAS WITHIN AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS 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 ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CORNEA WAS SCRATCHED DUE TO SURGEON CONDUCTED CATALYS OPERATION. IT WAS REPORTED THAT SURGEON OBSERVED CORNEA WAS WHITE-ISH JUST BEFORE THE OPTICAL COHERENCE TOMOGRAPHY IMAGE (PRIOR TO LASER BEING FIRED); HOWEVER WHEN ASKED, PATIENT DOES NOT HAVE HISTORY OF CORNEAL SCAR. SURGEON PROCEEDED AND COMPLETED THE CATALYS TREATMENT (CAPSULOTOMY, FRAGMENTATION AND CATARACT INCISIONS WERE SELECTED). WHEN ASKED THE ACCOUNT IF THEY SUGGESTED THE SCRATCH OF THE CORNEA WAS DONE BY THE LASER OR THE LIQUID OPTICS INTERFACE THE ANSWER WAS NO. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE ACCOUNT REGARDING ANY TREATMENT FOR THE CORNEA SCRATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771178 CATALYS SYSTEM CATALYS OOE ABBOTT MEDICAL OPTICS CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other