Z-2067-2015Class II

Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser...

Name: Z-2067-2015 Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser...
Creator: Nidek Inc
Published: 2015-03-25
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2015-03-25 / Terminated / root cause: labeling and UDI

FDA source

Nidek Inc began a recall of 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... on 2015-03-25. FDA classified it as Class II and gives the reason as "Accessories to the GYC-1000 laser were missing Laser Aperture labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2067-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-25
Posted: 2015-07-14
Terminated: 2015-07-14
Recalling firm: Nidek Incorporated
Product: 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.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Root cause tag: labeling and UDI
FDA root cause: 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: 22 units
Distribution: US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Product codes and lots: Model GYC4DD-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2067-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2067-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-14
Z-2068-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-14

Product code GEX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)