Reported Sep 18, 2013 · Terminated

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

Lumenis, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lumenis, Inc. · 3959 W 1820 S · Salt Lake City, UT · 84104

Is this the product you have?

  • Vision One Laser System Model GA-0025020
  • Serial No10050, 10051, 10053. Intended for use in the treatment of ocular pathology
Lot codes and dates
  • ModelGA-0025020
Amount recalled
3 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 19, 2013 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.