2,029 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
FDA Recall
Open, Classified
·Dutch Ophthalmic USA, Inc.·Product code HQF·April 14, 2021
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
FDA Recall
Open, Classified
·Ellex Medical Pty Ltd.·Product code HQF·March 16, 2023
Ellex Tango LT5106-T ophthalmic laser (not sold in USA)
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma
FDA Recall
Terminated
·Lumenis, Inc.·Product code HQF·August 15, 2014
Ellex Ultra Q LQP3106-U ophthalmic laser
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.
FDA Recall
Terminated
·Ziemer Usa Inc·Product code HQF·April 16, 2013
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
FDA Recall
Terminated
·Ziemer Usa Inc·Product code HQF·December 18, 2014
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQF·November 4, 2014
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQF·November 4, 2014