Device product
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.
Z-2068-2015
Product summary
- Firm
- Nidek Inc
- Event
- Event 71527
- Status
- Terminated
- Classification
- Class II
- Quantity
- W020 - 1 unit; 0Z20- 6 units
- Official record key
device-enforcement:Z-2068-2015
Official wording
Reason: Accessories to the GYC-1000 laser were missing Laser Aperture labels.
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.
Derived failure modes
-
Unknown
Accessories to the GYC-1000 laser were missing Laser Aperture labels.