BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 3122152 · Received May 17, 2013

    Report

    Report Number
    3005675890-2013-00013
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    January 1, 2012
    Report Date
    May 17, 2013
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE ANTERIOR TEARS REPORTED BY THE SURGEON IN THE (B)(4) PRESENTATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A USERS' GROUP MEETING HELD AT OPTIMEDICA HEADQUARTERS IN (B)(4), ON 04/18/2013, OPTIMEDICA BECAME AWARE OF A SURGEON WHO HAD ENCOUNTERED ANTERIOR CAPSULE TEARS IN MULTIPLE PTS DURING A RECENT STUDY, BUT THE EXTENT AND QUANTITY OF THE TEARS WERE UNK AT THAT TIME. ON 04/22/ 2013, AT THE (B)(4), THE SAME SURGEON PRESENTED (B)(4): IN THAT PRESENTATION, THE SURGEON REPORTED THAT (B)(4) (CONSISTING OF 399 EYES) ENCOUNTERED EIGHT ANTERIOR CAPSULE TEARS AND (B)(4) (CONSISTING OF 688 EYES) INVOLVED THIRTEEN ANTERIOR CAPSULE TEARS. (B)(4) TREATMENTS WERE PERFORMED SOLELY USING THE CATALYS SYSTEM MANUFACTURED BY OPTIMEDICA, WHILE (B)(4) DATA INCLUDED TREATMENT RESULTS DERIVED FROM THE CATALYS SYSTEM AS WELL AS ANOTHER MFR'S COMMERCIAL LASER PLATFORM. IT WAS UNCLEAR IN THE PRESENTATION AS TO WHICH ANTERIOR CAPSULE TEARS DESCRIBED IN (B)(4) WERE SPECIFICALLY ASCRIBED TO THE CATALYS SYSTEM. IT WAS ALSO UNCLEAR IF (B)(4) IS INCLUDED IN (AND THEREFORE A SUBSET OF) (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219122 CATALYS PRECISION LASER SYSTEM CATALYS OOE OPTIMEDICA CORPORATION CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1