miércoles, 23 de diciembre de 2015

FDA MedWatch - Hand-held Laser Pointers: FDA Safety Communication - Risk of Eye and Skin Injuries

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Hand-held Laser Pointers: FDA Safety Communication - Risk of Eye and Skin Injuries
AUDIENCE: Consumer, Pediatrics, Eye care, Dermatology, Emergency Medicine
ISSUE: FDA is reminding consumers about the risk of eye and skin injuries from exposure to products containing lasers. Although most toys with lasers are safe and comply with performance standards, some laser products such as hand-held laser pointers are being misused as toys. See FDA Safety Communication for Laser Pointer Safety video.
FDA regulations limit the visible light power of hand-held laser pointers to 5 milliwatts (mW). Even at the 5mW legal limit, a laser aimed directly into the eye can cause temporary flash blindness. This will not likely cause permanent injury, because most people have a protective reflexes such as looking away, blinking, or making other movements to protect the eyes. However, reflections of the laser beam from mirrors or metallic surfaces may not induce the protective reflex quickly enough to avoid injury. In addition, intentionally keeping your eyes open and staring into a 5 mW beam will cause eye injury.
BACKGROUND: Lasers that emit more than 5mW visible light power can cause irreversible eye injury of increasing severity as the power increases. High-powered laser pointers can irritate or even burn the skin. Although illegal and potentially dangerous, high-powered laser pointers are available on the Internet and in stores. FDA believes that many eye injuries from laser pointers go unreported. Nonetheless, the FDA is aware of laser pointer injuries involving military personnel, researchers, hobbyists and children. The FDA is aware of many child eye injuries caused when children play with laser pointers.  See FDA Safety Communication for description of incident reports.
RECOMMENDATION: The FDA wants to make consumers aware that they should not buy these lasers for themselves or as gifts for others. FDA recommends the following:
  • Do NOT buy laser pointers for children or allow them to use them. These products are not toys.
  • Do NOT buy any laser pointer that emits more than 5 mW power and does not have the power printed somewhere on the pointer or its packaging. Hand-held laser pointers over 5 mW and those that are not properly labeled are illegal and potentially dangerous.
  • Never aim or shine a laser beam directly at any person, pet, vehicle, or aircraft. The startling effect and temporary flash-blinding from a bright beam of light can cause serious accidents.
  • Do not aim a laser at any reflective surface such as a mirror or any other shiny surfaces where the beam cannot be controlled.
  • Check the label of any laser pointer that you own. If it has a power greater than 5 mW, dispose of it safely according to local environmental protection guidelines.
  • In the event of injury, immediately consult your eye doctor. Keep in mind that laser eye injuries are likely to be painless.
We have found that some lasers are more powerful than the labeled or advertised power. If you are not sure if your laser pointer is a high-powered laser, consider the following:
  • If the laser pointer is small and uses button batteries, its power is probably less than 5 mW.
  • If the laser pointer is pen-sized and runs on AA or AAA batteries, it's likely to be more powerful and may exceed 5 mW.
  • If the laser pointer is flashlight-sized and runs on a cluster of AA or AAA batteries or runs on lithium batteries, it likely exceeds 5 mW.
  • Laser pointers sold with battery chargers probably drain their batteries quickly and are very likely to be overpowered.
  • Some laser pointers are sold with a removable cap that spreads the beam into a pattern. If used without the cap, the beam becomes a single beam that could exceed 5 mW.
  • Sellers promoting high-powered laser pointers may use words such as: powerful, bright, ultra, super, military, military grade, super bright, high power, ultra bright, strong, balloon pop, burn, burning, adjustable focus, lithium battery, or lithium powered.
  • Videos or photos that show a laser with a bright, well-defined beam of light burning, melting, or popping balloons are probably lasers that greatly exceed 5 mW.
  • If comments posted on the website describe the brightness or power of the product, then it likely exceeds 5 mW.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the FDA Safety Communication at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm478746.htm

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