Array LaserLink — Class II medical device recall Z-2733-2014
Terminated recall by Lumenis, Inc., reported 2014-10-08, distributed nationwide. Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system
| Recall number | Z-2733-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lumenis, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2014-08-15 |
| Classified | 2014-09-30 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2014-10-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, JP |
| Quantity | 16 |
| Model numbers | GA-0006700 |
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
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.