BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 16158090 · Received January 13, 2023

    Report

    Report Number
    3012236936-2023-00116
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 15, 2022
    Report Date
    February 16, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE SYSTEM WAS NOT EVALUATED BY A FIELD SERVICE ENGINEER (FSE), CLINICAL SPECIALIST OR AREA SERVICE MANAGER (ASM). PERSONNEL WAS NOT DISPATCHED TO CUSTOMER SITE, OR NO RECORD OF A SERVICE VISIT IS RECORDED FOR THIS INCIDENT. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THERE WERE NO DISCREPANCIES OR NON-CONFORMANCES EXPERIENCED DURING MANUFACTURING. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISON, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3: DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE EVALUATION: THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE VALIDATED OCT OPERATION AND DAV, MOCK TREATMENT PASSED. THE SYSTEM WAS ADJUSTED AND RECALIBRATED. SYSTEM PERFORMING TO SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISON, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    ACCOUNT REPORTED ADVERSE EFFECT - POSTERIOR CAPSULE TEAR ENDED WITH AN ANTERIOR VITRECTOMY ON PATIENTS RIGHT (OD) EYE. SECONDARY LENS USED. PT SENT TO RETINA SURGEON. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529068 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention