BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 12204949 · Received July 21, 2021

    Report

    Report Number
    3006695864-2021-08133
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    March 8, 2021
    Report Date
    September 16, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H4 - MANUFACTURING DATE - THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS 12/09/2017 ADDITIONAL INFORMATION: A3 - 10/15/1953 DATE OF BIRTH AND GENDER MALE B3 - DATE OF EVENT - (B)(6) 2021 SECTION H6 CODING TYPE OF INVESTIGATION: 3331, 4109, 4110 INVESTIGATION FINDINGS: 213 DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO 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. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. H11 - PATIENT'S AFFECTED EYE IS RIGHT EYE. THE PATIENT HAD SULCUS INTRAOCULAR (IOL) LENS IMPLANTED PLACED INSTEAD OF TORIC IOL. PATIENT'S POSTOPERATIVE VISION IS 20/20 WITH CORRECTION.

    Additional Manufacturer Narrative · 1

    AGE, SEX, WEIGHT AND ETHNICITY: UNKNOWN/NOT PROVIDED. DATE OF EVENT- UNKNOWN/NOT PROVIDED. EQUIPMENT LABELING PROVIDES POTENTIAL ADVERSE EFFECTS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE OPERATOR MANUALS FOR THE VARIOUS EQUIPMENT WERE REVIEWED AND DETERMINED TO INCLUDE ADEQUATE WARNINGS FOR MEDICAL COMPLICATIONS. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CATARACT PROCEDURE THE POSTERIOR CAPSULE HAD A TEAR AND A VITRECTOMY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099661 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention