Staar Surgical AG
Monrovia, CA, US
STAAR SURGICAL AG appears in FDA device records in Monrovia, CA. FDA records list 24 510(k) clearances between and , 80 PMA records and 3 registered establishments. As of , FDA records show 24 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Staar Surgical AG between 1983 and 2017. The busiest year on record is 1986, with 5. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1985 | 4 |
| 1986 | 5 |
| 1988 | 1 |
| 1989 | 1 |
| 1991 | 1 |
| 1995 | 1 |
| 1998 | 2 |
| 2002 | 1 |
| 2004 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172375 | MicroSTAAR Injector System Cartridges | MSS | Substantially Equivalent | |
| K152357 | MicroSTAAR Injector System Cartridges | KYB | Substantially Equivalent | |
| K090161 | EPIPHANY INJECTION SYSTEM | MSS | Substantially Equivalent | |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | MSS | Substantially Equivalent | |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | MSS | Substantially Equivalent | |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | KYB | Substantially Equivalent | |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | HQC | Substantially Equivalent | |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | KYB | Substantially Equivalent | |
| K980696 | FOAM TIP INJECTOR | MSS | Substantially Equivalent | |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | KYB | Substantially Equivalent | |
| K913626 | SOFTRANS INJECTOR | HQL | Substantially Equivalent | |
| K884241 | STAAR PHACO XL SMALL INCISION SYSTEM | HQC | Substantially Equivalent | |
| K875099 | MOLTENO VALVE SETON | KYF | Substantially Equivalent | |
| K864071 | FAULKNER FORCEPS | HNR | Substantially Equivalent | |
| K861990 | SOFT LENS FOLDER | KYB | Substantially Equivalent | |
| K861085 | ELASTIC LENS INJECTOR TM | KYB | Substantially Equivalent | |
| K860544 | BACSTOP FILTER IRRIGATION SUPPLY KIT | KYG | Substantially Equivalent | |
| K860148 | MAZZOCCO/FRENCHIK FOLDER | KYB | Substantially Equivalent | |
| K852208 | PHACO-BAC STOP FILTER KIT | HQC | Substantially Equivalent | |
| K851936 | STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT | HQE | Substantially Equivalent | |
| K850900 | PHACO-BAC STOP KIT | HQC | Substantially Equivalent | |
| K850899 | I/A BAC STOP KIT | HQC | Substantially Equivalent | |
| K831172 | ULTRAKIT | HQC | Substantially Equivalent | |
| K831159 | I/A KIT | JSM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614429 | 3002808259 | STAAR SURGICAL AG | 104 HAUPTSTRASSE, NIDAU Bern CH-2560 CH | 2026 | |
| 2023826 | 2023826 | STAAR SURGICAL COMPANY | 1911 WALKER AVE., MONROVIA, CA 91016 US | 2026 | |
| 3014173684 | 3014173684 | STAAR Surgical Company | 15102 Red Hill Avenue, Tustin, CA 92780 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JSMCulture Media, Non-Propagating Transport
- KYGDevice, Irrigation, Ocular Surgery
- MSSFolders And Injectors, Intraocular Lens (Iol)
- HNRForceps, Ophthalmic
- KYFImplant, Eye Valve
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HQLIntraocular Lens
- KYBLens, Guide, Intraocular
- MTALens, Intraocular, Phakic
- MJPLens, Intraocular, Toric Optics
- QCBPhakic Toric Intraocular Lens
- HQCUnit, Phacofragmentation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2509-2026 | 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 power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No | Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses. | Class II | Open, Classified | |
| Z-1480-2026 | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 | Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal. | Class II | Open, Classified | |
| Z-0474-2024 | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Open, Classified | |
| Z-0473-2024 | 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. | Class II | Open, Classified | |
| Z-0472-2024 | 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. | Class II | Open, Classified | |
| Z-0471-2024 | 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. | Class II | Open, Classified | |
| Z-0470-2024 | 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. | Class II | Open, Classified | |
| Z-0469-2024 | EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Open, Classified | |
| Z-0468-2024 | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Open, Classified | |
| Z-0467-2024 | EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Open, Classified | |
| Z-0466-2024 | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Open, Classified | |
| Z-0465-2024 | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Open, Classified | |
| Z-0464-2024 | EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Open, Classified | |
| Z-1964-2016 | 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 Lenses). | Class II | Terminated | |
| Z-1747-2013 | 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. | STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. | Class II | Terminated | |
| Z-1746-2013 | 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 chamber and in the capsular bag through a tearfree capsulorhexis. | STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. | Class II | Terminated | |
| Z-2706-2011 | 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 intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy). | The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus. | Terminated | ||
| Z-1106-05 | Staarvisic II Sodium Hyaluronate, 0.8 mL | Sterility may be compromised. | Terminated | ||
| Z-0775-05 | STAAR Phaco Tubing Kit | Complaints of leaking with question of sterility and risk of infection in eye. | Terminated | ||
| Z-1037-04 | STAAR Surgical Intra Occular Lens, Collamer. | Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number. | Terminated | ||
| Z-0957-04 | MicroSTAAR Injector, MSI-PF Packed ten per box. | Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector. | Terminated | ||
| Z-0766-04 | MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF | Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use. | Terminated | ||
| Z-0539-04 | Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF | Risk of hyperopic refractive changes. | Terminated | ||
| Z-0378-04 | MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens) | Increased numbers of lens tears during placement of lens into eye. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain