BEUDAMED
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    PHACOFRAGMENTATION DEVICE - UNKNOWN MODEL

    FDA Adverse Event
    Injury ·UNK·Product code HQC·July 7, 2021

    DRUGS OF ABUSE HIGH

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAUHQCV3UK0·DRUGS OF ABUSE HIGH

    DAU HIGH QC

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAUHQCFSH0·DAU HIGH QC

    DAU HIGH

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAUV2HQCSH0·DAU HIGH

    DAU HIGH QC

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAUHQCV3FUHCMC0·DAU HIGH QC

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·August 5, 2016

    HQC 16602-3#HL-SET, OFFENES SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·December 19, 2014

    25GA COMBINED VITRECTOMY PACK WITH VALVES AND HQC

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB·Product code HQC·December 13, 2019

    UNK_PHACO TIP/NEEDLE

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code HQC·December 1, 2023

    Unit, Phacofragmentation

    FDA classification
    FDA Class 2 ·Unit, Phacofragmentation

    Constellation Vision System, Model: Constellation XT, Catalogue Number: 8065751548 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

    FDA Recall
    Terminated ·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010

    Constellation Vision System, Model: Constellation B, Catalogue Number: 8065751552 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

    FDA Recall
    Terminated ·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010

    Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.

    FDA Recall
    Terminated ·Bausch & Lomb Incorporated·Product code HQC·August 25, 2003

    Bausch & Lomb Thin Tip 30 angled Phaco Needle, Model DP8430AS, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HQC·January 8, 2010

    Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HQC·July 27, 2011

    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

    Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HQC·January 8, 2010