BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 11016157 · Received December 16, 2020

    Report

    Report Number
    3005675890-2020-00063
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    October 7, 2020
    Report Date
    December 28, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - CORRECTION: IN INITIAL REPORT, THE UNIQUE DEVICE IDENTIFIER (UDI) WAS MISSING. THE UDI IS (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CATALYS-U LASER 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. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARCUATE INCISION FULLY PENETRATED THE CORNEA RESULTING IN LEAKING ARCUATE INCISION AND ENDOPHTHALMITIS WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING THE CATALYS LASER PROCEDURE ON (B)(6) 2020, THE ARCUATE INCISION FULLY PENETRATED THE CORNEA. THE SURGEON DIDN'T DETECT THE PENETRATION AT THE TIME OF THE SURGERY AND THE SURGERY WAS COMPLETED WITHOUT ANY OTHER COMPLICATION. HOWEVER, POST-OPERATIVELY THE PATIENT DEVELOPED ENDOPHTHALMITIS WHICH THE SURGEON STATED WAS DUE TO THE LEAKING INCISION. FOLLOW UP WITH THE SURGEON REVEALED THAT THE PATIENT IS STILL GOING THROUGH TREATMENT AND HAS RECEIVED MULTIPLE ANTIBIOTICS INJECTIONS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483510 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention