6 results
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17ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
FDA Enforcement
Class I
·Terminated·Alcon Research, Ltd.·August 19, 2015
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
FDA Enforcement
Class I
·Terminated·Alcon Research, Ltd.·December 2, 2015
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
FDA Enforcement
Class I
·Terminated·Alcon Research, LTD.·October 31, 2018
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
FDA Enforcement
Class I
·Terminated·Alcon Research, LTD.·October 31, 2018
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
FDA Enforcement
Class I
·Terminated·Alcon Research, LTD.·October 31, 2018
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
FDA Enforcement
Class I
·Terminated·Alcon Research, LTD.·October 31, 2018