Collagen Corneal Shield
Ophthalmic · 21 CFR 886.4750
Recent MDR events
12 adverse event reports on file
- CORNEAL SHIELDSJan 8, 2016InjuryCynosure, Inc. Dba Ellman2428235-2016-00001
- PROSHIELDMar 2, 2007InjuryAlcon Laboratories, Inc., Oasis1610287-2007-00009
- PROSHIELDMar 2, 2007InjuryAlcon Laboratories, Inc., Oasis1610287-2007-00010
- SURGICAL SHIELDJun 15, 2005InjuryOcular Prosthetics Inc.617701
- CROUCH CORNEAL PROTECTORDec 12, 2001InjuryBausch & Lomb (storz Ophthalmes)378519
- Unnamed deviceDec 12, 2001Injury1920664-2001-00043
- CUSTOM PACKMay 18, 2001MalfunctionAlcon - Houston1644019-2001-00016
- ALCONMar 28, 2001MalfunctionAlconMW1021506
- PROSHIELDNov 1, 1996MalfunctionAlcon Laboratories, Inc.1610287-1996-00010
- PROSHIELDOct 11, 1996MalfunctionAlcon Labortories, Inc.1610287-1996-00008
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
12 firms currently registered for this product code
Bausch & Lomb Incorporated
Rochester, NY, US
Oasis Medical, Inc.
Glendora, CA, US
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Epsilon Eye Care Pvt., Ltd.
MUMBAI Maharashtra, IN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Microspecialties Llc
Middletown, CT, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Cheng Yi Optical (xiamen) Co., Ltd.
Xiamen Fujian, CN
Bausch & Lomb Incorporated
Saint Louis, MO, US
Alcon Research, Llc
Fort Worth, TX, US
Oasis Medical, Inc.
GLENDORA, CA, US
Sontec Instruments, Inc.
CENTENNIAL, CO, US
510(k) clearances
19 clearances for this product code
- Bausch & Lomb Healthcare and Optics WorldwideJul 26, 1995
K944872 · BIO-COR COLLAGEN CORNEAL SHIELD
- Chiron OphthalmicsMar 6, 1992
K915861 · MEDILENS-CS CORNEAL SHIELD
- Oasis Medical, Inc.Nov 13, 1991
K914529 · SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
- Vitaphore Corp.Oct 15, 1991
K913148 · COLLAGEN SHIELD FOR ACUTE CARE
- Chiron OphthalmicsJun 10, 1991
K905825 · COLLAGEN SHIELD, VARIOUS MODELS
- Vitaphore Corp.Aug 17, 1990
K902558 · COLLAGEN SHIELD FOR ACUTE CARE
- Chiron OphthalmicsJul 2, 1990
K901880 · MEDILENS(TM) CORNEAL SHIELD
- Intermedical, Inc.May 24, 1990
K896449 · IM COLLAGEN SHIELD