Staar Surgical Company
FDA Regulatory Profile
Staar Surgical Company appears in FDA public data with 16 recalls, 24 510(k) clearances, 11 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2509-2026, Class II) was initiated on April 20, 2026. Its most recent 510(k) clearance was granted on September 6, 2017.
Summary
- Total Recalls
- 16
- 510(k) Clearances
- 24
- Inspections
- 11
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2509-2026 | Class II | Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: T | April 20, 2026 |
| Z-1480-2026 | Class II | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 | January 21, 2026 |
| Z-0468-2024 | Class II | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens. | September 29, 2023 |
| Z-0470-2024 | Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens. | September 29, 2023 |
| Z-0474-2024 | Class II | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens. | September 29, 2023 |
| Z-0466-2024 | Class II | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. | September 29, 2023 |
| Z-0465-2024 | Class II | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens. | September 29, 2023 |
| Z-0471-2024 | Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens. | September 29, 2023 |
| Z-0467-2024 | Class II | EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens. | September 29, 2023 |
| Z-0469-2024 | Class II | EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. | September 29, 2023 |
| Z-0464-2024 | Class II | EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens. | September 29, 2023 |
| Z-0473-2024 | Class II | EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens. | September 29, 2023 |
| Z-0472-2024 | Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens. | September 29, 2023 |
| Z-1964-2016 | Class II | STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses. | May 2, 2016 |
| Z-1747-2013 | Class II | Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or o | June 10, 2013 |
| Z-1746-2013 | Class II | nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a c | June 10, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172375 | MicroSTAAR Injector System Cartridges | September 6, 2017 |
| K152357 | MicroSTAAR Injector System Cartridges | October 30, 2015 |
| K090161 | EPIPHANY INJECTION SYSTEM | June 9, 2009 |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | March 13, 2008 |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | March 13, 2008 |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | June 10, 2004 |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | May 16, 2002 |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | December 4, 1998 |
| K980696 | FOAM TIP INJECTOR | September 11, 1998 |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | December 21, 1995 |
| K913626 | SOFTRANS INJECTOR | December 18, 1991 |
| K884241 | STAAR PHACO XL SMALL INCISION SYSTEM | February 17, 1989 |
| K875099 | MOLTENO VALVE SETON | March 30, 1988 |
| K864071 | FAULKNER FORCEPS | November 13, 1986 |
| K861990 | SOFT LENS FOLDER | June 17, 1986 |
| K861085 | ELASTIC LENS INJECTOR TM | May 28, 1986 |
| K860544 | BACSTOP FILTER IRRIGATION SUPPLY KIT | April 4, 1986 |
| K860148 | MAZZOCCO/FRENCHIK FOLDER | March 21, 1986 |
| K851936 | STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT | August 20, 1985 |
| K852208 | PHACO-BAC STOP FILTER KIT | August 20, 1985 |