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
FDA Recall Z-2733-2014 · Posted 2014-09-30
Recalling FirmLumenis, Inc.
Recall StatusTerminated
Product CodeHQF
Date Initiated2014-08-15
Date Terminated2014-10-21
Product Quantity16
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.
Firm Action
Lumenis sent a Safety Advisory Notice dated July 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that Lumenis would contact consignees to schedule a product update, to be completed at a convenient time. For questions consignees should call 801-656-2549.
For questions regarding this recall call 801-656-2690.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
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.