BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 5193072 · Received October 30, 2015

    Report

    Report Number
    3005675890-2015-00060
    Event Type
    Injury
    Date Received
    October 30, 2015
    Date of Event
    October 10, 2015
    Report Date
    December 10, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE OF THIS REPORT WAS NOT POPULATED ON FOLLOW-UP #1, THE DATE SHOULD HAVE BEEN ENTERED AS 12/10/2015.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: ACCOUNT REPORTED DURING FOLLOW UP THAT DATE OF EVENT WAS (B)(6) 2015. ON THE INITIAL MDR SECTION WAS POPULATED WITH K121091. THIS FIELD SHOULD HAVE BEEN LEFT BLANK AS 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) # K121091. DEVICE EVALUATION: SYSTEM CHECKED AFTER THE EVENT AND NO TECHNICAL ISSUES WITH THE SYSTEM WERE FOUND. SYSTEM MEETS AMO SPECIFICATIONS. PATIENT TREATMENT FILES WERE CHECKED AND COULD NOT FIND ANY ABNORMALITIES. SINCE (B)(6) 2015 MANY MORE PROCEDURES HAVE BEEN DONE WITH NO ISSUE. SURGEON WAS REMINDED TO REMOVE THE CAPSULOTOMY WITH THE RECOMMENDED CONTINUOUS CURVILINEAR CAPSULORHEXIS (CCC) TECHNIQUE AND NOT BY PHACO DIRECTLY SUCKING IT UP. ADDITIONAL INFORMATION: DURING FOLLOW UP THE ACCOUNT REPORTED THAT THERE WAS NO PATIENT INJURY OR COMPLICATIONS AND NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). NO PATIENT FOLLOW UP IS REQUIRED. PATIENT WAS GIVEN TOPICAL STEROIDS. THE SURGEON REPORTED THAT CATALYS CONTRIBUTED TO THE INJURY.

    Description of Event or Problem · 1

    ACCOUNT REPORTED PATIENTS HAD A CAPSULE TEARS THAT WERE CAUSED BY AN INCOMPLETE CAPSULOTOMIES IN TWO PATIENTS. THIS REPORT IS FOR PATIENT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721933 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ABBOTT MEDICAL OPTICS CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other