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U.S. Department of Health and Human Services

Class 2 Device Recall Endophotocoagulation Delivery 4EP1 of GYC1000 Green Laser Photocoagulator System;

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  Class 2 Device Recall Endophotocoagulation Delivery 4EP1 of GYC1000 Green Laser Photocoagulator System; see related information
Date Initiated by Firm March 25, 2015
Date Posted July 14, 2015
Recall Status1 Terminated 3 on July 14, 2015
Recall Number Z-2068-2015
Recall Event ID 71527
510(K)Number K133358  K032085  
Product Classification Powered laser surgical instrument - Product Code GEX
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.
Code Information Model GYC4EP-01 0W02 and GYC4EP-1 0Z20; 
Recalling Firm/
Manufacturer		 Nidek Inc
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information Contact Neo Yamaguchi
510-353-7785
Manufacturer Reason
for Recall		 Accessories to the GYC-1000 laser were missing Laser Aperture labels.
FDA Determined
Cause 2		 Error in labeling
Action 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
Quantity in Commerce W020 - 1 unit; 0Z20- 6 units
Distribution US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = NIDEK CO., LTD
510(K)s with Product Code = GEX and Original Applicant = NIDEK, INC.
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