The Recall Desk

FDA (Devices) recall action 71527

Nidek Inc recalled 2 products on 2015-07-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-07-22
Critical
0
Units
22

Why these products were recalled

Accessories to the GYC-1000 laser were missing Laser Aperture labels.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2015-07-22

    Nidek GYC-1000 Laser Accessories Recalled for Missing Labels

    Nidek Inc is recalling GYC-1000 laser accessories because they are missing Laser Aperture labels. The affected units were distributed to 13 US states.

    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,
    Category
    Distribution
    14 states
  • ModerateFDA (Devices)··2015-07-22

    Nidek Green Laser Photocoagulator Accessories Recalled for Missing Labels

    Nidek Inc is recalling 22 units of GYC-1000 laser accessories because they are missing required Laser Aperture labels.

    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.
    Category
    Distribution
    14 states