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.
FDA Recall Z-2068-2015 · Posted 2015-07-14
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Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeGEX
Date Initiated2015-03-25
Date Terminated2015-07-14
Product QuantityW020 - 1 unit; 0Z20- 6 units
Reason for Recall
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Firm 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
Root Cause
Error in labeling
Distribution Pattern
US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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