CLASS II Device recall · Reported 8 Oct 2014 · FDA Enforcement Report

Array LaserLink recalled by Lumenis

Lumenis is recalling Array LaserLink, distributed nationwide in the US. The recall was initiated on 15 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll assembled units since product release, Part Number: GA-0006700.

Quantity recalled16

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2733-2014
FDA event ID: 69139
Recalling firm: Lumenis, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 15 Aug 2014
FDA classified: 30 Sep 2014
Reported: 8 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

15 Aug 2014	Recall initiated by company
30 Sep 2014	Classified by FDA	+46 days
8 Oct 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.

Product as listed by the FDA

Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.

Nationwide

Questions about this recall

Is Array LaserLink recalled?

Yes. Lumenis recalled Array LaserLink on 15 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-2733-2014.

Why was it recalled?

Which lots are affected?

All assembled units since product release, Part Number: GA-0006700.

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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