Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
This recall has been terminated (originally issued July 14, 2015).
- Company
- Nidek Inc
- Recall Initiated
- March 25, 2015
- Posted
- July 14, 2015
- Terminated
- July 14, 2015
- Recall Number
- Z-2067-2015
- Quantity
- 22 units
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Distribution
US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Lot / Code Info
Model GYC4DD-1
Root Cause
Error in labeling
Action Taken
Nidek sent Recall Notifications to doctors on March 31, 2015, by Federal Express. Letters were specific to the accessory involved. NIDEK detected that the laser aperture label has not been affixed on the delivery unit of GYC-1000, Green Laser Photocoagulator System and the device does not meet FDA regulation 21 CFR Subchapter J. In order to comply with FDA regulation, Nidek requests that the customer affix the enclosed laser aperture label to the Dual Delivery 4DD-1 of GYC-1000, according to the instructions attached. Please see the enclosed Laser Aperture label, instruction for affixing to the device and the response card. Nidek requests that you complete and return the response card as soon as possible. For additional information, please call Nidek at 1-800-223-9044 or visit http://usa.nidek.com