BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS LASER

    MDR report key: 15414682 · Received September 13, 2022

    Report

    Report Number
    3012236936-2022-02382
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    July 18, 2022
    Report Date
    February 9, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE (B)(6). PREMARKET IDENTIFICATION: 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) # K113479. DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, PRODUCT WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS 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

    CORRECTION: SECTION H4: INITIALLY IT WAS INADVERTENTLY REPORTED THAT DEVICE MANUFACTURE DATE WAS 2/24/2015, HOWEVER THE CORRECT MANUFACTURE DATE IS 2/4/2015. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AND DEVICE EVALUATION: SECTION H6: FOLLOWING WERE ADDED INVESTIGATIONAL FINDINGS - 180. INVESTIGATIONAL CONCLUSIONS - 4307. AT THE TIME OF THE INVESTIGATION, PRODUCT WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. 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 THERE WERE TAGS AND RENTS WITH CATALYS. COMPLICATIONS OCCURRED DUE TO TAGS WHERE THE BAG UNZIPPED IN THE RIGHT EYE AND THE PATIENT HAD TO HAVE THE DIU INTRAOCULAR LENS (IOL) REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON IOL (DIFFERENT MODEL, AR40E 20.0D) WHICH WAS SUTURED TO THE SCLERA. THE PATIENT HAD A VITRECTOMY DONE DURING THIS PROCEDURE. THE ISSUE WAS IDENTIFIED DURING THE CATALYS PROCEDURE AND IN POST-OP. THE PATIENT IS PERMANENTLY IMPAIRED/TEMPORARILY IMPAIRED. NO INCISION ENLARGEMENT WAS REQUIRED. THE END-USER DID NOT SEEK MEDICAL ATTENTION. SUTURES WERE NOT REQUIRED. THERE WAS NO DELAY IN PROCEDURE. NO MEDICATION WAS PRESCRIBED. DIRECTIONS FOR USE WERE FOLLOWED. VISUAL ACUITY (VA) PRE-OP: -5.25 +4.75 X 96; AV 20/50 DISTANCE VISION, INTERMEDIATE 20/40. THE PATIENT IS LEFT WITH UN-CORRECTED ASTIGMATISM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665919 CATALYS LASER OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention