BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 11705949 · Received April 22, 2021

    Report

    Report Number
    3006695864-2021-07543
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 22, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K200056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY: UNKNOWN/NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (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. 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 THE CATALYS 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CATARACT PATIENT EXPERIENCED A CORNEAL PERFORATION WHEN USING THE CATALYS LASER EQUIPMENT. A DESCRIPTION FROM THE SURGERY CENTER INDICATED WHILE MAKING THE PRIMARY CATARACT INCISION ON THE STEEP AXIS, TORIC MARKS FOR INTRAOCULAR LENS (IOL) ALIGNMENT PENETRATED THE ANTERIOR CORNEA SURFACE. THE SURGEON COMMENTS WERE THAT THE TORIC MARKS ARE PLANNED TO BE INTRASTROMAL AND SHOULD NOT PENETRATE THE ANTERIOR CORNEA. IN ADDITION, THE SURGEON MENTIONED THE EVENT OCCURRED WHEN THE CORNEAL MARKS AND INCISION ARE IN PROXIMITY. THE PATIENT OUTCOME REPORTED IS FULLY RECOVERED AND DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. PRE-OP: BCVA - 6/18P. POST-OP: UDVA - 6/12P.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605362 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other