Nidek Inc recalls Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; T…

Recall date

March 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2068-2015

FDA classification

Class II

Brand / firm

Nidek Inc

Sold / distributed

US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.

Why it was recalled

Accessories to the GYC-1000 laser were missing Laser Aperture labels.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.