BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINESSE REFLEX DSP FORCEPS

    MDR report key: 17732481 · Received September 12, 2023

    Report

    Report Number
    3003398873-2023-00191
    Event Type
    Injury
    Date Received
    September 12, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    UDI-DI
    07612717071568
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS IDENTIFIED WITHIN THE INDIVIDUAL ARTICLES AND THEREFORE WITHIN THIS COMPLAINT, WHICH IS WHY THE ASSOCIATED MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE, ENSURING THAT ALL PRODUCTS ON THE MARKET FULFILL THE RELEVANT REQUIREMENTS. SINCE THE LSR RETROSPECTIVELY REVIEW ARTICLES, NO SAMPLE IS AVAILABLE TO BE PROVIDED TO THE RESPONSIBLE SITE FOR AN IN-DEPTH INVESTIGATION. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE IDENTIFIED. THE EXACT ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. THEREFORE, NO SPECIFIC ACTION CAN BE TAKEN. AN OVERALL RISK ASSESSMENT WAS PERFORMED AND CONCLUDED THAT NO FURTHER ACTIONS ARE REQUIRED. ADDITIONALLY, COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ADVERSE TRENDS. NO ADDITIONAL ACTIONS ARE NEEDED. 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. LEE JY, JOO K, PARK SJ, WOO SJ, PARK KH. EPIRETINAL MEMBRANE SURGERY IN PATIENTS WITH MULTIFOCAL VERSUS MONOFOCAL INTRAOCULAR LENSES. RETINA, THE JOURNAL OF RETINAL AND VITREOUS DISEASES. 2021;41(12):2491-2498. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    AN AUTHOR REPORTED VIA LITERATURE REPORTED THAT PATIENT EXPERIENCED SWELLING OF THE ARCUATE RETINAL NERVE FIBER LAYER AND DISSOCIATED OPTIC NERVE FIBER LAYER RELATED TO THE SURGICAL TRAUMA OF THE INNER RETINA WHICH IS CAUSED BY OPHTHALMIC FORCEPS. CURRENT PATIENT CONDITION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633941 FINESSE REFLEX DSP FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG NA ASKU 07612717071568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other