Medical Devices

The FDA Recommends Against Using Laserworld and Ray Technologies International Laser Projectors: FDA Safety Communication

Date Issued:
November 7, 2017

Audiences:

  • Night club operators, entertainment venues and laser light show manufacturers that have or are considering purchasing Laserworld or Ray Technologies International laser projectors
  • Dealers and distributors of Laserworld and Ray Technologies International products

Device:
Laser projectors manufactured by Laserworld USA, Inc., Laserworld (Switzerland) AG, and Laserworld (ASIA) Co Ltd (hereafter Laserworld), are designed to generate visual effects for the purpose of demonstration, entertainment, advertisement, or artistic composition using high-powered lasers. This includes projectors labelled as Ray Technologies International GmbH (RTI). These high powered laser products are commonly used at night clubs, concerts, and outdoor light shows and may expose members of the public, performers, and operators to potentially harmful laser radiation. FDA has determined that this safety information applies to Laserworld Class IIIb and Class IV laser projectors distributed since 2008.

Purpose:
The FDA is recommending entertainment venues, and other laser light show manufacturers stop using Laserworld and RTI Class IIIb and Class IV laser projectors because they lack required safety features that protect the user and general public from harmful exposures to high-powered laser radiation. Missing features can include a manual reset mechanism and remote interlock connector. These features prevent unintended laser exposures that can be harmful.

Summary of Problem and Scope:
The FDA discovered through sample testing and reviewing manufacturer-provided user manuals that multiple Laserworld Class IIIb and Class IV laser projector model series were lacking required safety features, did not function in a safe manner, and were lacking important user information. Since September 2013, the FDA has worked with and taken action against Laserworld. Some of these actions include a face-to-face meeting and correspondence with Laserworld, a recall, a warning letter, issuing an import alert, and denying Laserworld’s request for variance (FDA approval that allows a manufacturer to deviate from a required performance standard). Laserworld’s responses to these actions have been incomplete and have not sufficiently addressed FDA’s safety concerns.

On January 30, 2017, Laserworld’s manufacturing facility in Lake Mary, FL, was inspected by FDA. The inspection determined that Laserworld’s quality testing program was ineffective and incapable of certifying that their products comply with the Federal performance standard for laser products. Before the inspection could be completed, Laserworld closed the Lake Mary location.

Laserworld failed to complete corrective actions, did not notify affected persons, and failed to submit an acceptable corrective action plan concerning Club Series laser projectors. They also continued to certify and market Class IIIb and Class IV laser projectors without an FDA approved variance. The FDA is concerned that users of Laserworld projectors are unaware of the following:

  • Many Laserworld and RTI Class IIIb and Class IV lasers projectors do not comply with the applicable Federal performance standards.
  • Laser light shows that use noncompliant Laserworld or RTI laser projectors are potentially dangerous and prohibited under Federal law.
  • Laserworld and RTI laser projectors that do not have a variance are not compliant with Federal performance standards. They cannot be used in laser light shows before a variance is obtained from the FDA.
  • Laserworld and RTI cannot certify, demonstrate, or otherwise introduce or deliver for introduction into commerce, or import Class IIIb and IV laser projectors until they obtain an approved variance from the FDA.

Recommendations:
The FDA recommends that those who purchased Laserworld laser projectors, including RTI laser projectors, stop using them immediately. In addition, potential customers should refrain from purchasing Laserworld / RTI Class IIIb and Class IV laser projectors.

In the event of an eye injury, immediately consult your eye doctor. Keep in mind that laser eye injuries are likely to be painless.

FDA Actions:
Since 2013, the FDA has been working with Laserworld and RTI to address concerns about the safety of their products.

The FDA will continue to work with Laserworld A.G. to bring these products into regulatory compliance and will keep the public informed if significant new information becomes available.

This safety communication is in keeping with the FDA’s commitment to inform the public about safety issues.

Reporting Problems to the FDA:
Prompt reporting of accidental radiation occurrences can help the FDA identify and better understand the risks related to use of these high powered laser products. If you suspect or are aware of a potential laser injury, please complete the accidental radiation occurrence form, FDA Form 3649.

This information will assist the FDA in collecting laser product injury cases and in investigating the circumstances surrounding the injuries. It will also help the FDA develop trends that indicate if laser injuries from certain products are increasing or decreasing over time.

Contact Information:
If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.
 

Page Last Updated: 11/07/2017
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