Nidek Inc: Medical Device Recall in 2015 - (Recall #: Z-2068-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 25, 2015

Date Posted: July 22, 2015

Recall Number: Z-2068-2015

Event ID: 71527

Reason for Recall:

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

Status: Terminated

Product Quantity: W020 - 1 unit; 0Z20- 6 units

Code Information:

Model GYC4EP-01 0W02 and GYC4EP-1 0Z20;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated