Company ยท US
Staar Surgical Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2017. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
24recalls (2 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KYB | Lens, Guide, Intraocular | 11 |
| MTA | Lens, Intraocular, Phakic | 8 |
| HQC | Unit, Phacofragmentation | 6 |
| HQL | Intraocular Lens | 6 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 5 |
| QCB | Phakic Toric Intraocular Lens | 5 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 |
| HNR | Forceps, Ophthalmic | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| KYF | Implant, Eye Valve | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 |
| LZP | Aid, Surgical, Viscoelastic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 6, 2017 | K172375 | MicroSTAAR Injector System Cartridges STAAR Surgical Company | MSS |
| Oct 30, 2015 | K152357 | MicroSTAAR Injector System Cartridges STAAR Surgical Company | KYB |
| Jun 9, 2009 | K090161 | EPIPHANY INJECTION SYSTEM Staar Surgical Co. | MSS |
| Mar 13, 2008 | K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM Staar Surgical Co. | MSS |
| Mar 13, 2008 | K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM Staar Surgical Co. | MSS |
| Jun 10, 2004 | K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S Staar Surgical Co. | KYB |
| May 16, 2002 | K020734 | SURGE-FREE ASPIRATION ADAPTER Staar Surgical Co. | HQC |
| Dec 4, 1998 | K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) Staar Surgical Co. | KYB |
| Sep 11, 1998 | K980696 | FOAM TIP INJECTOR Staar Surgical Co. | MSS |
| Dec 21, 1995 | K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) Staar Surgical Co. | KYB |
| Dec 18, 1991 | K913626 | SOFTRANS INJECTOR Staar Surgical Co. | HQL |
| Feb 17, 1989 | K884241 | STAAR PHACO XL SMALL INCISION SYSTEM Staar Surgical Co. | HQC |
| Mar 30, 1988 | K875099 | MOLTENO VALVE SETON Staar Surgical Co. | KYF |
| Nov 13, 1986 | K864071 | FAULKNER FORCEPS Staar Surgical Co. | HNR |
| Jun 17, 1986 | K861990 | SOFT LENS FOLDER Staar Surgical Co. | KYB |
| May 28, 1986 | K861085 | ELASTIC LENS INJECTOR TM Staar Surgical Co. | KYB |
| Apr 4, 1986 | K860544 | BACSTOP FILTER IRRIGATION SUPPLY KIT Staar Surgical Co. | KYG |
| Mar 21, 1986 | K860148 | MAZZOCCO/FRENCHIK FOLDER Staar Surgical Co. | KYB |
| Aug 20, 1985 | K852208 | PHACO-BAC STOP FILTER KIT Staar Surgical Co. | HQC |
| Aug 20, 1985 | K851936 | STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT Staar Surgical Co. | HQE |
| Mar 29, 1985 | K850900 | PHACO-BAC STOP KIT Staar Surgical Co. | HQC |
| Mar 29, 1985 | K850899 | I/A BAC STOP KIT Staar Surgical Co. | HQC |
| Jun 8, 1983 | K831172 | ULTRAKIT Staar Surgical Co. | HQC |
| Apr 28, 1983 | K831159 | I/A KIT Staar Surgical Co. | JSM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Staar Surgical AG Product Name: STAAR ICL Calculation Software
Software Version: Version 8.00
Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter po Open, Classified |
MTA | None listed |
| Mar 2, 2026 | Staar Surgical AG EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 Open, Classified |
QCB | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens. Open, Classified |
MTA | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens. Open, Classified |
QCB | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens. Open, Classified |
QCB | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens. Open, Classified |
QCB | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens. Open, Classified |
QCB | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. Open, Classified |
MTA | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens. Open, Classified |
MTA | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens. Open, Classified |
MTA | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. Open, Classified |
MTA | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens. Open, Classified |
MTA | None listed |
| Dec 1, 2023 | Staar Surgical Company EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens. Open, Classified |
MTA | None listed |
| May 2, 2016 | Staar Surgical Co. STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses. Terminated |
KYB | K940593 |
| Jul 17, 2013 | Staar Surgical Co. Afinity CQ2015A Intraocular Lens
The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. Terminated |
HQL | None listed |
| Jul 17, 2013 | Staar Surgical Co. nanoFLEX CC4204A Intraocular Lens
Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior c Terminated |
HQL | None listed |
| Jun 29, 2011 | Staar Surgical Co. Brand Name
STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single
Piece Foldable Intraocular Lens
Common Names
Collamer single piece IOL
Collamer plate haptic IOL
The Device is intend Terminated |
HQL | None listed |
| Aug 6, 2005 | Staar Surgical Co Inc Staarvisic II
Sodium Hyaluronate, 0.8 mL Terminated |
LZP | None listed |
| Apr 27, 2005 | Staar Surgical Co Inc STAAR Phaco Tubing Kit Terminated |
GDY | None listed |
| Jul 20, 2004 | Staar Surgical Co Inc STAAR Surgical Intra Occular Lens, Collamer. Terminated |
HQL | None listed |
| Jul 20, 2004 | Staar Surgical Co Inc MicroSTAAR Injector, MSI-PF
Packed ten per box. Terminated |
KYB | K980696 |
| Jul 20, 2004 | Staar Surgical Co Inc MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF Terminated |
KYB | None listed |
| Feb 18, 2004 | Staar Surgical Co Inc Collamer UV One-Piece IntraOcular Lens.
Models 4205BF and 4204BF Terminated |
HQL | None listed |
| Jan 29, 2004 | Staar Surgical Co Inc MicroSTAAR Injector Cartridges Models:
SFC-25 (utilized with plate haptic Collamer lens)
MTC-60 (utilized with plate haptic Silicone lens) Terminated |
KYB | None listed |