BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 11742136 · Received April 28, 2021

    Report

    Report Number
    3006695864-2021-07583
    Event Type
    Injury
    Date Received
    April 28, 2021
    Report Date
    May 7, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H4: CORRECTION: IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS JAN 28, 2014, HOWEVER THE CORRECT DATE IS 06/20/2013 . A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED, AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WERE REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS. AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED. THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED. AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR CATALYSE SYSTEM (S/N#: (B)(6)), SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    WEIGHT, ETHNICITY: UNKNOWN, NOT PROVIDED. DATE OF EVENT IS UNKNOWN AS IT WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS RECEIVED BASED ON A CLINICAL STUDY FROM A RESEARCH INSTITUTION: STUDY NAME: A COMPARISON OF VENTURI AND PERISTALTIC BASED PHACOEMULSIFICATION IN FEMTOSECOND LASER CATARACT SURGERY. A RESEARCH INSTITUTE REPORTED A PATIENT WAS DIAGNOSED WITH CYSTOID MACULAR EDEMA FOLLOWING CATARACT SURGERY WHEN USING THE CATALYS SYSTEM FEMTOSECOND LASER AND WHITESTAR SIGNATURE PRO PHACOEMULSIFICATION SYSTEM. DESCRIPTION OF EVENT: A RESEARCH INSTITUTE REPORTED A PATIENT WAS DIAGNOSED WITH CYSTOID MACULAR EDEMA FOLLOWING CATARACT SURGERY WHEN USING THE CATALYS SYSTEM FEMTOSECOND LASER AND WHITESTAR SIGNATURE PRO PHACOEMULSIFICATION SYSTEM. AT A ONE-MONTH POST OP EXAM, THE PATIENT RETURNED TO REFERRING OPTOMETRIST WITH EDEMA AND WORSENING VISION. AT THAT TIME, THE PATIENT WAS PRESCRIBED STEROID DROPS TO RESOLVE SYMPTOMS. AT A 3-MONTH POST OP EXAM, THE VISION HAD DETERIORATED FURTHER. THE PATIENT WAS PRESCRIBED BROMSITE AND PREDNSOLONE EYE DROPS AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). THE PATIENT WAS SCHEDULED TO RETURN TO CLINIC IN 3 WEEKS. ADDITIONAL NARRATIVE FROM THE CLINIC: THIS IS A DESCRIBED COMPLICATION/RISK FOR CATARACT SURGERY AND IS LIKELY NOT RELATED TO THE RESEARCH STUDY. THIS SUBJECT¿S CONDITION WAS ACCELERATED DUE TO HIM NOT FILLING THE STEROID PRESCRIPTION AFTER SEEING HIS REFERRING OPTOMETRIST. OUTCOME: ONGOING / CONTINUING TREATMENT: IT WAS REPORTED THE EVENT INTERRUPT A PARTICIPANT¿S USUAL DAILY ACTIVITY AND MAY REQUIRE SYSTEMIC DRUG THERAPY OR OTHER TREATMENT. AS OF APRIL 13TH, OUTCOME PATIENT RECEIVED SUBTENON KENALOG INJECTION IN BOTH EYES FOR CME(CYSTOID MACULAR EDEMA). TODAY¿S (OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SLIGHT IMPROVEMENT COMPARED TO PREVIOUS STUDY. RELATIONSHIP TO STUDY INTERVENTION: NOT RELATED: THERE IS NOT A REASONABLE POSSIBILITY THAT THE ADMINISTRATION OF THE STUDY INTERVENTION CAUSED THE EVENT, THERE IS NO TEMPORAL RELATIONSHIP BETWEEN THE STUDY INTERVENTION AND EVENT ONSET, OR AN ALTERNATE ETIOLOGY HAS BEEN ESTABLISHED. EXPECTEDNESS BASED FROM THE RESEARCH STUDY: EXPECTED. THIS REPORT IS FOR THE CATALYS SYSTEM. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SIGNATURE PRO EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633117 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SIGNATURE PRO EQUIPMENT