Federal safety officials are warning about a risk of serious and long-term eye damage that may be caused by certain laser projects used at night clubs, entertainment venues and during light shows.
In a Safety Communication issued on November 7, the U.S. Food and Drug Administration (FDA) indicated that certain high-powered lasers sold and distributed by Laserworld and Ray Technologies International may expose members of the public, performers and operators to potentially harmful laser radiation.
The agency is asking entertainment venues, and other laser light show producers, to stop using Laserworld RTI Class IIIb and Class IV laser projectors, because they lack required safety features that are designed to prevent unintended laser exposure that may result in eye injuries and other problems.
Class IV laser products are the most dangerous class of lasers available on the market, and can quickly cause long term eye damage if not used properly and in a safe manner. Class IV lasers are powerful enough to burn skin and materials, especially dark or lightweight materials in a close range.
Exposure to a Class IV laser can cause significant eye damage, depending on the duration and strength of that exposure. If the beam is directed or deflected toward an individual’s eye, it could cause devastating and permanent eye damage, and if exposed for an extended period of time, could result in blindness.
The warning is linked to projectors manufactured by Laserworld USA, Inc. (Switzerland, and Laserworld (ASIA) Company Ltd. They were distributed and sold throughout the United States.
The FDA has been working with Laserworld since September 2013, and has taken several actions to bring the manufacturer’s products up to par with federal safety standards including having face-to-face meetings, sending written correspondence, issuing a recall of their products, sending them warning letters, and issuing safety alerts to the public. However, the FDA still finds that the devices could be a threat and do not meet safety standards.
On January 30, 2017, FDA officials inspected Laserworld’s manufacturing plant in Lake Mary, Florida, and determined the company’s quality testing program was ineffective and incapable of certifying that their products comply with the Federal performance standards for laser products. Prior to the conclusion of the inspection, Laserworld closed its Lake Mary facility.
Several of the violations found that many of the Class IIIb and Class IV laser projectors did not comply with Federal performance standards. They were considered potentially dangerous and prohibited for sale under Federal law. The manufacturer failed to obtain a variance issued by the FDA to be sold for light shows, and the company was unable to certify, demonstrate, or otherwise introduce or deliver the product into commerce legally under federal safety standards.
Additionally, the FDA claims the manufacturer failed to provide safety features with the equipment such as manual reset mechanism, and remote interlock connector, which are designed to prevent unintended laser exposures that can be harmful.
The FDA is warning those who have purchased Laserworld projectors, including RTI Class IIIb and Class IV laser projectors, to stop using them immediately and should report any adverse events including accidental radiation occurrences to the FDA by filling out the Department of Health and Human Resources Accidental Radiation Occurrence Report.