BEUDAMED
    53 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

    FDA Recall
    Open, Classified ·Dutch Ophthalmic USA, Inc.·Product code HQC·May 21, 2019

    TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision Inc·Product code HQC·April 6, 2022

    Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·March 14, 2024

    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code HQC·April 28, 2025

    Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024

    Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024

    Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024

    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024

    Constellation Procedure Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Centurion FMS Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Alcon Custom Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Constellation Vision System, REF: 8065751150

    FDA Recall
    Open, Classified ·Alcon Research, LLC·Product code HQC·August 18, 2023

    Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024

    Single-Use Packs, REF: OPO80

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·December 7, 2022

    Legion FMS Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·September 1, 2022

    Veritas Advanced Infusion Packs, REF: VRT-AI

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·December 7, 2022

    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code HQC·August 5, 2025

    VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code HQC·May 30, 2023