Events

Recall of Lumenis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lumenis, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69139
  • Event Risk Class
    Class 2
  • Event Number
    Z-2733-2014
  • Event Initiated Date
    2014-08-15
  • Event Date Posted
    2014-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129733
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laser, ophthalmic - Product Code HQF
  • 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.
  • Action
    Lumenis sent a Safety Advisory Notice dated July 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that Lumenis would contact consignees to schedule a product update, to be completed at a convenient time. For questions consignees should call 801-656-2549. For questions regarding this recall call 801-656-2690.

Device

Lumenis
  • Model / Serial
    All assembled units since product release, Part Number: GA-0006700.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
  • 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
  • Manufacturer
    Lumenis, Inc.

Manufacturer

Lumenis, Inc.
  • Manufacturer Address
    Lumenis, Inc., 3959 W 1820 S, Salt Lake City UT 84104
  • Manufacturer Parent Company (2017)
    Laguna Holdco Ltd
  • Source
    USFDA