353 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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
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
Bausch & Lomb Millennium Premium Venturi Phaco Pack, Model DP4310 and DP4310E, 6 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
Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 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
Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
FDA Recall
Terminated
·Allergan Medical Optics Inc·Product code HQC·March 29, 2004
Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114, 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
Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
FDA Recall
Terminated
·Alcon Research, LTD. 9965 Buffalo Speedway·Product code HQC·January 12, 2018
Bausch & Lomb Thin Tip 30 Phaco Needle, Model DP8430S, 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 MicroFlow 2.2 30 Phaco Needle, Model DP8730S, 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
Constellation Vision System, Model: Constellation Tabletop, Catalogue Number: 8065751150 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
Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQC·June 2, 2015
Alcon 25+ TOT ALPLUS Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
FDA Recall
Terminated
·Alcon Research, LTD. 9965 Buffalo Speedway·Product code HQC·January 12, 2018
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQC·August 31, 2012
Bausch & Lomb MicroFlow 45 Phaco Needle, Model DP8245S, 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
Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled 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 MicroFlow Plus 30 Phaco Needle, Model DP8330S, 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