Lumenis, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2191-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.

Product Classification:

Class II

Date Initiated: August 19, 2013

Date Posted: September 18, 2013

Recall Number: Z-2191-2013

Event ID: 66133

Reason for Recall:

Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

Status: Terminated

Product Quantity: 3 units

Code Information:

Model: GA-0025020

Distribution Pattern:

Distributed in the states of NJ, PA, and IL.

Voluntary or Mandated:

Voluntary: Firm initiated