7 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
FDA Enforcement
Class I
·Ongoing·Bausch & Lomb Surgical, Inc.·May 14, 2025
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
FDA Enforcement
Class I
·Ongoing·Bausch & Lomb Surgical, Inc.·May 14, 2025
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
Carina Sub-Acute Care Ventilator
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·August 30, 2023
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019