BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 12763810 · Received November 7, 2021

    Report

    Report Number
    2028159-2021-01298
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    September 30, 2021
    Report Date
    March 21, 2022
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380657517633
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHACOEMULSIFICATION SYSTEMS ARE CLOSED SYSTEMS. THEY ARE OPERATED WITH A STERILE SINGLE USE CONSUMABLE CASSETTE WHICH IS DESIGNED TO ISOLATE THE PATIENT FLUID PATH FROM THE CONSOLE ITSELF. ANY SURGICAL INSTRUMENTATION THAT WOULD COME INTO CONTACT WITH THE PATIENT WOULD BE CLEANED AND AUTOCLAVED BY THE USER PRIOR TO SURGERY, PER STANDARD INDUSTRY PRACTICES AND COMPANY DIRECTIONS FOR USE (DFU). THE PROPER CLEANING AND STERILIZATION OF OPHTHALMIC SURGICAL INSTRUMENTS CAN HELP PREVENT THE OCCURRENCE OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THESE FINDINGS CONTINUE TO VALIDATE THE NEED TO FOLLOW THE RECOMMENDATIONS DETAILED IN THE DFUS, ASSOCIATION OF PERIOPERATIVE REGISTERED NURSES (AORN) RECOMMENDED PRACTICES, AND THE AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY (ASCRS) TASS TASK FORCE GUIDANCE DOCUMENT. THERE IS NO EVIDENCE THAT THE DESIGN OR MANUFACTURING OF THE SYSTEM CONTRIBUTED TO THE REPORTED EVENT. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. NO SERVICE RECORD RELEVANT TO THE COMPLAINT REPORTED EVENT WAS FOUND. THE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR WAS COMPLETED AND REVIEWED BY QA TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER REPORTED EVENTS CANNOT BE CONFIRMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENTS IS INCONCLUSIVE. THE MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS REPORT REPRESENT THE THIRD PATIENT OF THREE FROM THIS FACILITY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED POST-OPERATIVELY WITH NO SIGNS OF SYMPTOMS. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 4+ AQUEOUS CELL AND 2+ AQUEOUS FIBRIN. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE ANTIBIOTIC AND STEROID EYE DROPS. NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE BEEN RESOLVING WITHOUT ANY ADDITIONAL TREATMENT. THIS IS THE FIRST OF FOUR REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658305 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA 00380657517633

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other ACRYSOF SINGLEPIECE IOL| BSS STERILE IRRIGATING SOLUTION| BSS WITH VANCOMYCIN| CUSTOM-PAK SURGICAL PROCEDURE PACK| INTRACAMERAL LIDOCAINE| LIDOCAINE GEL| OFLOXACIN| POVIDONE IODINE 10%| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE| SURGICAL PRODUCT, UNSPECIFIED