342 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Peregrine 20 GA Endo Ocular Adjustable Laser Probe
FDA Recall
Terminated
·Peregrine Surgical Ltd·Product code HQF·July 19, 2010
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
FDA Recall
Terminated
·Nidek Inc·Product code HQF·October 24, 2012
Ellex Solo LT5106-S ophthalmic laser (not sold in USA)
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. )
FDA Recall
Terminated
·Ellex USA·Product code HQF·June 13, 2007
Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
FDA Recall
Terminated
·Ellex USA·Product code HQF·June 13, 2007
Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009
Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.
FDA Recall
Terminated
·Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany·Product code HQF·February 3, 2014
Ellex Super Q LQP3106 ophthalmic laser
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
FDA Recall
Terminated
·Nidek Inc·Product code HQF·June 9, 2014
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
FDA Recall
Terminated
·Laserex Systems Inc.·Product code HQF·February 1, 2016
Opthalmic Laser, product number 8065-5000-1
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQF·April 9, 2004
Model LightLas 532 Opthalmic Photocoagulator Laser
FDA Recall
Terminated
·LightMed USA Inc·Product code HQF·November 11, 2003
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
FDA Recall
Terminated
·Nidek Inc·Product code HQF·May 24, 2013
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
FDA Recall
Terminated
·Nidek Inc·Product code HQF·March 27, 2012
Alcon 3000LE ophthalmic laser
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and posterior segments of the eye.
FDA Recall
Terminated
·Alcon Laboratories, Inc.·Product code HQF·September 26, 2008
Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
FDA Recall
Terminated
·Lumenis, Inc.·Product code HQF·July 27, 2010
Bausch & Lomb Millennium Advanced Flow System Phaco Pack, Model CX5310, 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 HQF·January 8, 2010
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQF·November 4, 2014