BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON SURGICAL KNIFE/BLADE

    MDR report key: 11826317 · Received May 14, 2021

    Report

    Report Number
    2523835-2021-00162
    Event Type
    Injury
    Date Received
    May 14, 2021
    Report Date
    August 23, 2021
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF THERE WERE TASS CASES; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. EVEN THOUGH NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; OUR PRODUCTS ARE PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION IS AVAILABLE, THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SIX PATIENTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. A COMPLETED QUESTIONNAIRE WAS RECEIVED. DURING THE PROCEDURE THE INITIAL INCISION SITE WAS RELOCATED DUE TO THE SHALLOW ANTERIOR CHAMBER OF THE PATIENT TO COMPLETE THE CAPSULAR RHEXIS. THE FIRST INCISION WAS SUTURED. THE PATIENT REQUIRED ADDITIONAL MEDICAL TREATMENT WITH COMPOUNDED ANTIBIOTIC, STEROID AND NON-STEROIDAL DROPS IN THE RIGHT EYE. CURRENT PATIENT CONDITION WAS NOT REPORTED. THIS REPORT REPRESENTS PATIENT SIX OF THE SIX PATIENTS FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721256 ALCON SURGICAL KNIFE/BLADE KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention DUOVISC| EPINEPHINE 1:1000| INFINITI VISION SYSTEM| PHENYLEPHRINE 2.5| POLYMYXIN| PROPARACAINE| SODIUM BICARB| TROPICAMIDE 1%| ZCBOO 20.0 IOL| DUOVISC| EPINEPHINE 1:1000| INFINITI VISION SYSTEM| PHENYLEPHRINE 2.5| POLYMYXIN| PROPARACAINE| SODIUM BICARB| TROPICAMIDE 1%| ZCBOO 20.0 IOL