10 results
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31ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·June 3, 2015
G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
FDA Recall
Terminated
·Volk Optical Inc·Product code HKS·June 30, 2008
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Recall
Terminated
·Volk Optical Inc·Product code HJK·February 27, 2015
Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
FDA Recall
Terminated
·Volk Optical Inc·Product code KYB·January 23, 2009
Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
FDA Recall
Terminated
·Volk Optical Inc·Product code HJK·February 2, 2016
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Recall
Terminated
·Volk Optical Inc·Product code HJL·October 25, 2012
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
FDA Recall
Terminated
·Volk Optical Inc·Product code HJI·February 27, 2015
Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·March 23, 2016
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·March 27, 2013
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·July 15, 2015