Staar Surgical Co.
Medical device manufacturer in Nidau, Swit.
24510(k) clearances
3PMA approvals
17recalls
Device types
- KYB Lens, Guide, Intraocular 7
- HQC Unit, Phacofragmentation 6
- MSS Folders And Injectors, Intraocular Lens (Iol) 5
- JSM Culture Media, Non-Propagating Transport 1
- HQE Instrument, Vitreous Aspiration And… 1
- KYG Device, Irrigation, Ocular Surgery 1
- HNR Forceps, Ophthalmic 1
- KYF Implant, Eye Valve 1
- HQL Intraocular Lens 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K172375 | MicroSTAAR Injector System CartridgesMSS · Special | 09/06/2017SE |
| K152357 | MicroSTAAR Injector System CartridgesKYB · Special | 10/30/2015SE |
| K090161 | Epiphany Injection SystemMSS · Traditional | 06/09/2009SE |
| K073591 | Microstaar Msi Injector Foam Tip SystemMSS · Traditional | 03/13/2008SE |
| K073586 | Microstaar Indigo Injector Foam Tip SystemMSS · Traditional | 03/13/2008SE |
| K032412 | Re-Useable Microstaar Injector, Msi-SKYB · Traditional | 06/10/2004SE |
| K020734 | Surge-Free Aspiration AdapterHQC · Traditional | 05/16/2002SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | 12/04/1998SE |
| K980696 | Foam Tip InjectorMSS · Traditional | 09/11/1998SE |
| K954600 | Microstaar Injector Models Msi-Td & Msi-Pd (Modification)KYB · Traditional | 12/21/1995SE |
| K913626 | Softrans InjectorHQL · Traditional | 12/18/1991SE |
| K884241 | Staar Phaco XL Small Incision SystemHQC · Traditional | 02/17/1989SE |
| K875099 | Molteno Valve SetonKYF · Traditional | 03/30/1988SE |
| K864071 | Faulkner ForcepsHNR · Traditional | 11/13/1986SE |
| K861990 | Soft Lens FolderKYB · Traditional | 06/17/1986SE |
| K861085 | Elastic Lens Injector TMKYB · Traditional | 05/28/1986SE |
| K860544 | Bacstop Filter Irrigation Supply KitKYG · Traditional | 04/04/1986SE |
| K860148 | Mazzocco/Frenchik FolderKYB · Traditional | 03/21/1986SE |
| K852208 | Phaco-Bac Stop Filter KitHQC · Traditional | 08/20/1985SE |
| K851936 | STAAXL-3 Small Incision System TM, PhacofragmentatHQE · Traditional | 08/20/1985SE |
| K850900 | Phaco-Bac Stop KitHQC · Traditional | 03/29/1985SE |
| K850899 | I/A Bac Stop KitHQC · Traditional | 03/29/1985SE |
| K831172 | UltrakitHQC · Traditional | 06/08/1983SE |
| K831159 | I/A KitJSM · Traditional | 04/28/1983SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2509-2026 Class II | Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product…Due to a software coding issues for calculating the implant orientation diagram printout for the… | 04/20/2026Open, Classified |
| Z-1480-2026 Class II | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled… | 01/21/2026Open, Classified |
| Z-0474-2024 Class II | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0473-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0472-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0471-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0470-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0469-2024 Class II | EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0468-2024 Class II | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0467-2024 Class II | EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0466-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0465-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-0464-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | 09/29/2023Open, Classified |
| Z-1964-2016 Class II | STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular… | 05/02/2016Terminated |
| Z-1747-2013 Class II | Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of…STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular… | 06/10/2013Terminated |
| Z-1746-2013 Class II | nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in…STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular… | 06/10/2013Terminated |
| Z-2706-2011 | Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece…The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar… | 05/20/2011Terminated |