Lumenis, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2733-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 15, 2014

Date Posted: October 8, 2014

Recall Number: Z-2733-2014

Event ID: 69139

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.

Status: Terminated

Product Quantity: 16

Code Information:

All assembled units since product release, Part Number: GA-0006700.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.

Voluntary or Mandated:

Voluntary: Firm initiated