FDA Approves Dry-Eye Medication

"Drug regulators in the United States have approved Xiidra, which is lifitegrast ophthalmic solution 5 percent, to treat dry eye disease," reports Medical News Today. "Xiidra is the first prescription eye drop approved to treat both the signs and symptoms of dry eye - a group of conditions where the tear fluid produced by the eyes is either insufficient to lubricate the eyes properly, or of the wrong consistency." Read more.FDA, Food & Drug Administration, Xiidra, Dry Eye,

FDA Updates Warning about Peroxide as a Contact Lens Cleaning Solution

Under new regulations, there will be a red warning label and red tip remind your patients that contact lens solutions with hydrogen peroxide require special handling. (This is a sample bottle. Actual products may have a different design, depending on the brand.)

Manufacturers of Impact-Resistant Lenses Put on FDA Alert List

The Food & Drug Administration has added two lens exporters to its list of companies failing to comply with FDA regulations: Jiangxi Look Optical Industrial Co., Ltd., and Koadak Optical Ind. Com., Ltd. Here's the FDA's reason: "Eyeglasses and sunglasses imported into the United States are required to comply with 21 CFR 801.410, "Use of impact-resistant lenses in eyeglasses and sunglasses". A certificate to comply with 21 CFR 801.410(g) must accompany each entry of eyeglasses and sunglasses showing the lens manufacturer has conducted tests of the lenses using the impact test described in paragraph (d)(2) of 21 CFR 801.410 or any equal or superior test. It has been reported that certificates from foreign manufacturers may not be valid. Tests by one U.S. distributor revealed 40-70% breakage which differed significantly from the manufacturer's certificate. Due to apparent certificate irregularities SAN-DO collected a sample of children's sunglasses. The manufacturer's certificate indicated that no lenses broke during testing. However, WEAC testing of the sample found that nearly every lens broke completely. More recently, SAN-DO collected a sample of adult prescription lenses. WEAC testing of the sample found that 38% of the lenses broke completely." Read more.

Homeland Security Seizes 20,000 Pairs of Contact Lenses

“With Halloween rapidly approaching, federal officials are warning the public about the dangers associated with counterfeit decorative contact lenses. Decorative and colored lenses are becoming increasing popular, especially around this time of year,” according to the Houston News. “Currently, the Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI), U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) and U.S. Customs and Border Protection (CBP) are working to seize counterfeit contact lenses, illegally imported decorative lenses, and lenses unapproved by the FDA. This ongoing effort, which is being coordinated with the ICE-led National Intellectual Property Rights Coordination Center (IPR Center) in Washington, is being called ‘Operation Double Vision.’ As a result of the operation, this year alone there have been 74 seizures with a total of more than 20,000 pairs of counterfeit and decorative contact lenses being seized.” Read more.

FDA Gives Contact Lens Manufacturers a Year to Comply with UDI Rule

“Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry,” reports RAPS.org. One group: Contact Lens manufacturers. “In an announcement this week, FDA indicated that at least one group of devices had been granted an extension. Class III contact lens and intraocular lens labelers, FDA said, would have until September 2015 to label their products in accordance with the UDI rule's direct marking requirements. The reason for the delay, FDA explained, was because of the likelihood of an ‘extremely large number of data submissions to the Global Unique Device Identification Database (GUDID)’—a number so large that FDA implied it might be a burden upon both the industry and its database.”  Read more.

New FDA Materials Warn about Dangers of Decorative Contact Lenses

d

FDA brochure about the use of decorative contact lenses.

The FDA is launching a  campaign about the dangers of decorative contact lenses--more precisely the use of them without the fit of an OD or ophthalmologist. It's borrowing from the horror video genre that has inspired so many teenagers to slap on the color altering devices. The message also is backed by the American Optometric Association (AOA) and the Entertainment Industries Council (EIC). The three organizations produced and are distributing two public service videos designed to attract young people. The FDA has also released a brochure available at this link.

American Horror Story Helps Deliver Safety Message

The video, first screened at the recent AOA annual conference, uses clips from the television show American Horror Story, along with clips of professional makeup artists and optometrists. They note that before an actor or any individual can wear these lenses, he or she must have an eye exam, valid CL prescription, and lenses purchased from a reputable source.For more information about the program, click here.

Hollywood Joins FDA Decorative CL Campaign

The U.S. Food & Drug Administration (FDA), American Optometric Association (AOA) and the Entertainment Industries Council (EIC) have teamed up with entertainment industry-leading artists from the TV series American Horror Story on a first-of-its-kind decorative contact lens campaign to bring the dramatic realities of illegal and unsafe lens use to the forefront. “Artists and technicians work closely with each other, the actors, and doctors to ensure proper fit, vision and safety. We wouldn’t put our actors’ health in danger, and the viewers who want to emulate these characters shouldn’t either,” said technician Christien Tinsley, Tinsley Studios and Makeup Effects Designer for American Horror Story. The campaign launches just in time for end-of-school-year celebrations, a time when students are more likely to purchase and use decorative contact lenses. The premier of the first public service announcement in the series was held April 22nd at the 18th Annual PRISM Awards in Los Angeles. Read more.

FDA Red-Lists Sunglass Manufacturer

The FDA (U.S. Food & Drug Administration) "red-listed" Linhai Industrial Glasses (LIG) Factory, Duchuan 387 The Road , Linhai City, China, for its non-prescription sunglasses. That means Customs agents can detain without physically examining LIG eyewear with impact-resistant lenses.

The red-listing process began with a U.S. distributor. The firm heard reports about LIG's eyewear. It tested a shipment and found a breakage rate ranging from 40 to 70 percent. That's when the FDA became involved. The federal agency notes, "Due to apparent certificate irregularities SAN-DO collected a sample of children's sunglasses. The manufacturer's certificate indicated that no lenses broke during testing. However, WEAC testing of the sample found that nearly every lens broke completely. More recently, SAN-DO collected a sample of adult prescription lenses. WEAC testing of the sample found that 38% of the lenses broke completely." Eyeglasses and sunglasses imported into the U.S. must comply with 21 CFR 801.410: "Use of impact-resistant lenses in eyeglasses and sunglasses." A certificate of compliance, which testifies that the lens manufacturer has tested lenses for compliance, must accompany each shipment. In the past three years, the FDA has red-listed several manufacturers in China. Read more.