Staar Surgical Co.
Staar Surgical Co. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2009, with 3 FDA device recalls on record.
Top product codes for Staar Surgical Co.
FDA recalls by Staar Surgical Co.
- Z-1964-2016 — STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Staar Surgical Co.
- K090161 — EPIPHANY INJECTION SYSTEM
- K073586 — MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
- K073591 — MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
- K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S
- K020734 — SURGE-FREE ASPIRATION ADAPTER
- K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
- K980696 — FOAM TIP INJECTOR
- K954600 — MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
- K913626 — SOFTRANS INJECTOR
- K884241 — STAAR PHACO XL SMALL INCISION SYSTEM
- K875099 — MOLTENO VALVE SETON
- K864071 — FAULKNER FORCEPS
- K861990 — SOFT LENS FOLDER
- K861085 — ELASTIC LENS INJECTOR TM
- K860544 — BACSTOP FILTER IRRIGATION SUPPLY KIT
- K860148 — MAZZOCCO/FRENCHIK FOLDER
- K851936 — STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
- K852208 — PHACO-BAC STOP FILTER KIT
- K850899 — I/A BAC STOP KIT
- K850900 — PHACO-BAC STOP KIT
- K831172 — ULTRAKIT
- K831159 — I/A KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.