BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 20550468 · Received October 28, 2024

    Report

    Report Number
    3012236936-2024-000291
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 3, 2024
    Report Date
    December 9, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 DEVICE EVALUATED BY MANUFACTURER: YES. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN APPLICATION SUPPORT MANAGER (ASM) WAS AT SITE PROVIDING SURGERY SUPPORT AND REPORTED THAT ON A CASE, DOCTOR MOVED THE SIDE PORT TO 0.5MM LIMBUS OFFSET. WHEN IN THE OPERATING ROOM (OR) DOCTOR DID NOT ATTEMPT TO OPEN ANY CATARACT INCISION AND WENT AHEAD WITH BLADE. DURING THE SURGERY DOCTOR MENTIONED THAT SHE WAS SEEING SOME EDEMA BY MAIN INCISION. ASM ASKED DOCTOR IF SHE WAS NOT ABLE TO SEE THE CATALYS CATARACT INCISION AND MADE THE INCISION WITH BLADE. DOCTOR MENTIONED THAT SHE USED THE BLADE TO OPEN THE CATARACT INCISION MADE WITH CATALYS. ASM INFORMED DOCTOR THAT SHE NEEDS TO USE A BLUNT INSTRUMENT TO OPEN ANY INCISION MADE WITH CATALYS. DOCTOR WILL PUT PATIENT ON SOME ANTI-INFLAMMATION FOR EDEMA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915935 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention