Class II — Lumenis, Inc.
| Recalling firm | Lumenis Be Ltd. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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… |
| Quantity | 16 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA. |
| Initiated | 2014-08-15 |
| Classified | 2014-09-30 |
| Terminated | 2014-10-21 |
| Recall number | Z-2733-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Lumenis, Inc. (Z-2733-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69139/
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