Eye, Artificial, Non-custom
Ophthalmic · 21 CFR 886.3200
Recent MDR events
10 adverse event reports on file
- PROSTHETIC EYEMay 15, 2025InjuryKolberg Ocular Products Inc.MW5170425
- MEDPOR SPHEREJan 27, 2005InjuryPorex Surgical1057129-2005-00005
- NLCON POSTERIOR CHAMBER LENSJul 10, 1992MalfunctionAlcon Surgical Inc3721
- ALCON POSTERIOR CHAMBER LENSJul 10, 1992MalfunctionAlcon Surgical Inc3722
- ALCON POSTERIOR CHAMBER INTRAOCULAR LENSJul 10, 1992MalfunctionAlcon Surgical Inc3724
- ALCON POSTERIOR CHAMBER INTRAOCULAR LENSJul 10, 1992MalfunctionAlcon Surgical Inc3726
- ALCON POSTERIOR CHAMBER INTRAOCULAR LENSJul 10, 1992MalfunctionAlcon Surgical Inc3730
- ALCON POSTERIOR CHAMBER INTRAOCULAR LENSJul 10, 1992MalfunctionAlcon Surgical Inc3732
- ALCON POSTERIOR CHAMBER INTRAOCULAR LENSJul 10, 1992MalfunctionAlcon Surgical Inc3733
- ALCON POSTERIOR CHAMBER LENSJul 10, 1992MalfunctionAlcon Surgical Inc3734
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
28 firms currently registered for this product code
Lights' Prosthetic Eyes, Inc.
Peoria, IL, US
Stephens Instruments, Inc
LEXINGTON, KY, US
Iscon Surgicals, Ltd.
JODHPUR Rajasthan, IN
Akriti Ophthalmic Private Limited
Hyderabad Telangana, IN
Texas Eye Prosthetics Llc
HOUSTON, TX, US
June R.r. Nichols, Ocularist Ltd. D/b/a Ocularists Ltd
DES PLAINES, IL, US
Steven R. Young Ocularist, Inc.
OAKLAND, CA, US
Soper Brothers & Associates
HOUSTON, TX, US
Eye Prosthetics Of Wisconsin, Inc.
BROOKFIELD, WI, US
Cantor Barnard Ltd
NORTHAMPTONSHIRE, GB
Paul Instruments (india)
CALCUTTA West Bengal, IN
Inami & Co., Ltd.
Bunkyo Tokyo, JP
Stony Brook
Shakopee, MN, US
Black & Black Surgical, Inc.
Tucker, GA, US
Thompson Ocular Prosthetics, Inc.
Olmos Park, TX, US
Jardon Eye Prosthetics, Inc.
SOUTHFIELD, MI, US
Ocular Prosthetics, Inc.
Los Angeles, CA, US
M/s Tarun Enterprises
Prayagraj, Uttar Pradesh, IN
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Midwest Eye Laboratories, Inc.
Eau Claire, WI, US
The Eye Concern, Inc.
MESA, AZ, US
Legrand Assoc.
Broomall, PA, US
Midwest Eye Laboratories, Inc.
ROCHESTER, MN, US
Midwest Eye Laboratories Sioux Falls Llc
SIOUX FALLS, SD, US
Indo-german Surgical Corporation
Mumbai Maharashtra, IN
510(k) clearances
6 clearances for this product code
- Robert B. Scott Ocularists of Florida, Inc.Jun 26, 1995
K952538 · ROBERT B. SCOTT PLASTIC ARTIFICAL
- Daniel T AcostaMay 30, 1995
K945270 · CUSTOM ARTIFICIAL HUMAN EYES
- Frank Tanaka, Ocularist, Inc.Mar 22, 1995
K946226 · CUSTOM OCULAR PROSTHESIS
- Nissel , Ltd.Sep 2, 1992
K923167 · THE NISSEL ARTIFICIAL EYE
- Midwest Eye Laboratories, Inc.Aug 30, 1991
K904962 · EYE ARTIFICIAL CUSTOM
- Ocularists , Ltd.Jan 10, 1980
K791923 · SCLERAL POWDER