Home / Companies / Staar Surgical AG

Staar Surgical AG

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
24
Inspections
11
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1480-2026Class IIEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5January 21, 2026
Z-0474-2024Class IIEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.September 29, 2023
Z-0468-2024Class IIEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.September 29, 2023
Z-0466-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.September 29, 2023
Z-0467-2024Class IIEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.September 29, 2023
Z-0471-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.September 29, 2023
Z-0464-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.September 29, 2023
Z-0473-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.September 29, 2023
Z-0465-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.September 29, 2023
Z-0470-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.September 29, 2023
Z-0472-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.September 29, 2023
Z-0469-2024Class IIEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.September 29, 2023
Z-1964-2016Class IISTAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.May 2, 2016
Z-1747-2013Class IIAfinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or oJune 10, 2013
Z-1746-2013Class IInanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cJune 10, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K172375MicroSTAAR Injector System CartridgesSeptember 6, 2017
K152357MicroSTAAR Injector System CartridgesOctober 30, 2015
K090161EPIPHANY INJECTION SYSTEMJune 9, 2009
K073591MICROSTAAR MSI INJECTOR FOAM TIP SYSTEMMarch 13, 2008
K073586MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEMMarch 13, 2008
K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SJune 10, 2004
K020734SURGE-FREE ASPIRATION ADAPTERMay 16, 2002
K983129DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)December 4, 1998
K980696FOAM TIP INJECTORSeptember 11, 1998
K954600MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)December 21, 1995
K913626SOFTRANS INJECTORDecember 18, 1991
K884241STAAR PHACO XL SMALL INCISION SYSTEMFebruary 17, 1989
K875099MOLTENO VALVE SETONMarch 30, 1988
K864071FAULKNER FORCEPSNovember 13, 1986
K861990SOFT LENS FOLDERJune 17, 1986
K861085ELASTIC LENS INJECTOR TMMay 28, 1986
K860544BACSTOP FILTER IRRIGATION SUPPLY KITApril 4, 1986
K860148MAZZOCCO/FRENCHIK FOLDERMarch 21, 1986
K852208PHACO-BAC STOP FILTER KITAugust 20, 1985
K851936STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTATAugust 20, 1985