BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 13957465 · Received March 30, 2022

    Report

    Report Number
    3012236936-2022-00778
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 2, 2022
    Report Date
    March 30, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF BIRTH, WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOCTOR LOST SUCTION ON A PATIENT DURING THE CAPSULOTOMY TREATMENT. THE DOCTOR REGAINED SUCTION AND COMPLETED THE LENS FRAGMENTATION AND ARCUATE INCISIONS. DURING CATARACT REMOVAL, THERE WAS AN ANTERIOR TEAR TO THE CAPSULAR BAG. DOCTOR WAS ABLE TO SUCCESSFULLY COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128551 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other