Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory in...
FDA Device Recall #Z-2733-2014 — Class II — August 15, 2014
Recall Summary
| Recall Number | Z-2733-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 15, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Lumenis, Inc. |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 16 |
Product Description
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
Lot / Code Information
All assembled units since product release, Part Number: GA-0006700.
Other Recalls from Lumenis, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0194-2022 | Class I | IPL Coupling Gel, I L (AX1009013), 12 pack of 0... | Oct 14, 2021 |
| Z-2191-2013 | Class II | Vision One Laser System Model GA-0025020, Seria... | Aug 19, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.