# Staar Surgical Co.

- Location (FDA's records): Monrovia, CA
- FDA decisions: 27 (1983–2017): 24 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Staar Surgical Co. (24); STAAR Surgical Company (3)
- Product codes: KYB (7), HQC (6), MSS (5), HQL (2), KYF (1), HQE (1), HNR (1), JSM (1), KYG (1), MTA (1)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 15 (3 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Staar Japan: 2 (https://510kreport.com/company/staar-japan)
- Surgin Surgical Instrumentation, Inc.: 1 (https://510kreport.com/company/surgin-surgical-instrumentation)
- Syntec, Inc.: 1 (https://510kreport.com/company/syntec)
- Paradigm Medical Industries, Inc.: 1 (https://510kreport.com/company/paradigm-medical-industries)
- Rayner Surgical, Inc.: 1 (https://510kreport.com/company/rayner-surgical)
- Chiron Vision Corp.: 1 (https://510kreport.com/company/chiron-vision)
- Pharmacia & Upjohn Co.: 1 (https://510kreport.com/company/pharmacia-upjohn)
- Staar Sugical: 1 (https://510kreport.com/company/staar-sugical)

## Firms that cite its devices most
- Staar Japan: 3 (https://510kreport.com/company/staar-japan)
- Lenstec, Inc.: 2 (https://510kreport.com/company/lenstec)
- New World Medical, Inc.: 2 (https://510kreport.com/company/new-world-medical)
- Alcon Laboratories: 2 (https://510kreport.com/company/alcon-laboratories)
- Sis Ltd., Surgical Instrument Systems: 1 (https://510kreport.com/company/sis-surgical-instrument-systems)
- Anton Meyer & Co., Ltd.: 1 (https://510kreport.com/company/anton-meyer)
- Advanced Medical Optics, Inc.: 1 (https://510kreport.com/company/advanced-medical-optics)

## Its most-cited devices
- K980696: Foam Tip Injector (1998), cited by 3
- K983129: Disposable Microstaar Injector (Model Msi-P1) (1998), cited by 2
- K875099: Molteno Valve Seton (1988), cited by 2
- K913626: Softrans Injector (1991), cited by 2
- K861085: Elastic Lens Injector TM (1986), cited by 1
- K073591: Microstaar Msi Injector Foam Tip System (2008), cited by 1

## Recent decisions
- K172375: MicroSTAAR Injector System Cartridges (Sep 6, 2017)
- K152357: MicroSTAAR Injector System Cartridges (Oct 30, 2015)
- K090161: Epiphany Injection System (Jun 9, 2009)
- K073591: Microstaar Msi Injector Foam Tip System (Mar 13, 2008)
- K073586: Microstaar Indigo Injector Foam Tip System (Mar 13, 2008)
- P030016: Visian Icl (Implantable Collamer Lens) (Dec 22, 2005)
- K032412: RE-Useable Microstaar Injector, Msi-S (Jun 10, 2004)
- K020734: Surge-Free Aspiration Adapter (May 16, 2002)

Source page: https://510kreport.com/company/staar-surgical