BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 14698857 · Received June 15, 2022

    Report

    Report Number
    3012236936-2022-01576
    Event Type
    Injury
    Date Received
    June 15, 2022
    Report Date
    June 15, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH (MONTHS): AGES ARE 75 YEARS, 75 YEARS AND 65 YEARS, GENDER: SEX/GENDER: 2 FEMALE AND 1 MALE, WEIGHT AND ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS FEBRUARY 14, 2022 MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER OF THE COMPLAINT PRODUCT IS UNKNOWN. SINCE THE SERIAL NUMBER IS UNKNOWN, THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: SINCE THE SAMPLE OF THE COMPLAINT PRODUCT WAS NOT RETURNED, AND SERIAL NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO DETERMINE A MALFUNCTION AND/OR PRODUCT QUALITY DEFICIENCY. DEVICE MANUFACTURE DATE: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. CITATION: KODAVOOR, S. K., V, P., DANDAPANI, R., & RAMAMURTHY, C. (2022). CORNEAL PERFORATION FOLLOWING ARCUATE KERATOTOMY IN FEMTOSECOND LASER ASSISTED CATARACT SURGERY-A CASE SERIES. AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS, 26, 101432. HTTPS://DOI.ORG/10.1016/J.AJOC.2022.101432.

    Description of Event or Problem · 0

    A CASE SERIES WAS DONE FOR THE IDENTIFICATION AND MANAGEMENT OF CORNEAL PERFORATION DURING ARCUATE KERATOTOMY IN FEMTOSECOND LASER ASSISTED CATARACT CASES (FLACS). THREE CASES (N=3 EYES) WERE INCLUDED WHEREIN FLACS WAS PERFORMED USING AN OPTICAL COHERENCE TOMOGRAPHY (OCT) BASED FEMTOSECOND LASER (CATALYS, OPTIMEDICA CORP). ALL CASES REPORTED SUCTION LOSS (N=3 EYES) CAUSED BY A SLIGHT EYE MOVEMENT OR UNCOOPERATIVE PATIENT, WHICH LED TO FULL THICKNESS INCISION AT THE ARCUATE KERATOTOMY (AK) INCISION SITE (CORNEAL PERFORATION)(N=3 EYES) FOLLOWING FEMTOLASER ARCUATE KERATOTOMY (FSAK). IN THESE 3 CASES, THE PROCEDURE WAS ABORTED AND WAS SHIFTED ON TO THE OPERATING TABLE. ADDITIONALLY, HYPOTONY AND FLAT ANTERIOR CHAMBER WERE ALSO REPORTED. ALL THE 3 CASES WERE MANAGED BY PLACING SUTURE AT THE KERATOTOMY SITE FOLLOWED BY PHACOEMULSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156163 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention