FDA.reportPublic FDA data

Eyeball prosthesis, custom-made

Definition
An artificial substitute for the eyeball, resembling the anterior portion of the eye, made to individual specifications. It is usually constructed of glass or plastic and is intended to be inserted into a patient/user's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. This device is not intended to be implanted.
GUDID devices
11
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
G542V26230Artificial EyeTHE EYE CONCERN, INC.V26232024-01-10
PROSV2623Soper Brothers CustomSoper Brothers, Incorporated12026-03-03
SHELLV2627Soper Brothers CustomSoper Brothers, Incorporated12026-03-03
00860015162809Dallas Eye ProstheticsDallas Eye Prosthetics12025-12-23
00860015162816Dallas Eye ProstheticsDallas Eye Prosthetics12025-12-23
G568V2623Artificial Eye, Plastic, CustomTHOMPSON OCULAR PROSTHETICS, INC.V26232025-03-10
B796V2623Eye, Artificial, Non-CustomMIDWEST EYE LABORATORIES, INC.V26232024-03-27
G519V2623Eye, Artificial, Non-CustomMidwest Eye Laboratories Sioux Falls, LLCV26232024-03-10
G290V2623Eye, Artificial, Non-CustomMidwest Eye Laboratories Woodbury, LLCV26232024-02-19
G521V2623Artificial Eye, Plastic, CustomLegrand AssociatesV26232023-10-18
B863E661087V2623Artificial Eye, Plastic, CustomTEXAS EYE PROSTHETICS LLCV26232020-04-14