FDA Device recall Z-2733-2014
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pat…
- FDA Device
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pat… by Lumenis, citing 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 dif….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2733-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-15 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lumenis |
| Distribution | US |
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
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.
Identifiers
| code_info | All assembled units since product release, Part Number: GA-0006700. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2733-2014%22
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