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U.S. Department of Health and Human Services

Class 2 Device Recall Lumenis

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  Class 2 Device Recall Lumenis see related information
Date Initiated by Firm August 15, 2014
Date Posted September 30, 2014
Recall Status1 Terminated 3 on October 21, 2014
Recall Number Z-2733-2014
Recall Event ID 69139
510(K)Number K130195  
Product Classification Laser, ophthalmic - Product Code HQF
Product 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
Code Information All assembled units since product release, Part Number: GA-0006700.
Recalling Firm/
Manufacturer		 Lumenis, Inc.
3959 W 1820 S
Salt Lake City UT 84104
For Additional Information Contact Mr. Rick Gaykowski
801-656-2690
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 16
Distribution Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQF and Original Applicant = LUMENIS, INC.
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