Reported Oct 8, 2014 · Terminated
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the…
Lumenis, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lumenis, Inc. · 3959 W 1820 S · Salt Lake City, UT · 84104
Is this the product you have?
- 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
- Lot codes and dates
- All assembled units since product release
- Part NumberGA-0006700
- Amount recalled
- 16
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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