LOS ANGELES– The owners and operators of 10 Southern California businesses were charged today in federal court with illegally selling cosmetic contact lenses without prescriptions. Some of the products that were purchased in connection with this investigation were contaminated with dangerous pathogens that can cause eye injury, blindness and loss of the eye.

The 10 criminal informations filed late this afternoon charge the store operators with selling “misbranded” contact lenses because they were sold without prescriptions. The products that were allegedly illegally sold were marketed as Halloween and beauty accessories under names such as Wonder Look, Red Rose, Black & White, Beauty World and Crazy Eagle.

“Contact lenses that fit the eye poorly could cause eye damage, including scratches on the cornea, corneal infection, conjunctivitis, decreased vision and blindness,” according to the charging documents. “Under California law, a California resident retailer could only sell and/or dispense contact lenses if the retailer was a licensed physician or surgeon, licensed optometrist, registered dispensing optician, or a pharmacist.”

“These products pose a serious danger to unsuspecting Halloween shoppers, and those who have already purchased these products should not use them,” said United States Attorney Eileen M. Decker. “As required by the law, contact lenses should be used only when they are prescribed by a knowledgeable medical professional.”

The cases filed this week are the result of Operation “Fright Night,” which targeted retail stores – some of which were selling Halloween costumes and accessories – that sold cosmetic and decorative contact lenses without a prescription to unsuspecting consumers in Southern California.

The investigation was conducted by the United States Food and Drug Administration's (FDA's) Import Operations Branch of the Los Angeles District Office; the FDA's Office of Criminal Investigations; the California Department of Public Health; and the California Department of Consumer Affairs' Division of Investigation, Health Quality Investigation Unit.

“Consumers rely on FDA oversight to ensure the safety of their contact lenses. Buying decorative or ‘fashion' contact lenses without a valid prescription puts consumers' health – and their vision – at risk,” said George M. Karavetsos, director, FDA Office of Criminal Investigations. “The FDA is committed to working with our law enforcement partners to keep such products out of the U.S. marketplace.”

Contact lenses – whether corrective, cosmetic or decorative – are considered to be prescription medical devices subject to FDA regulations. Due to the risk of injury, blindness and possible eye infection, all contact lenses require prescriptions from medical professionals who can provide guidance on the proper care and maintenance of the contact lenses.

“This joint operation is important because wearing these decorative lenses is dangerous and can cause serious injury, which potentially can result in blindness or the loss of an eye if they are not properly prescribed by a licensed eye care professional,” said Dr. Karen Smith, the director of the California Department of Public Health and the state public health officer. “Those who sell these lenses without obtaining a prescription put people at risk. Operation Fright Night is a great example of our joint commitment to protect public health from the risk of eye-related illness and injury from these prescription medical devices.”

Cassandra Hockenson, the spokesperson for the Medical Board of California, stated: “The Medical Board of California's primary mission is consumer protection, and it is imperative to get the word out to the public on the dangers of selling contact lenses without a proper prescription from a licensed medical professional.”

The 10 cases filed this week in United States District Court in Los Angeles charge these defendants:

· Arianna Beauty, Inc., which is located on Santee Street in downtown Los Angeles, and its owner, Farshid Ben Cohen, 53, of Los Angeles;

· Alex Mario Collantes Marxelly, 40, of San Bernardino, the owner of Zebra Accessories in San Bernardino;

· Kathy Hwang, 51, of Chino Hills, doing business as Fashion 20 in La Puente;

· Hollywood Toys & Costumes, Inc. in Hollywood, and the store's owner, Rezvan Moazzez, also known as Ron Moazzez, 69, of Encino;

· Sin Young Yi, 59, of Chino Hills, the owner of Yi's Accessories in the Central Mercado Mini Mall in La Puente;

· Susie Shin, 52, of La Mirada, the owner of My Treasure in Buena Park;

· J2 Trading, Inc., doing business as Hairitage Beauty Supply in San Bernardino and J2's owner, Dong Ki Min, 51, of Chino Hills;

· Fashion 4-U, Inc., doing business as Fashion Dream in Garden Grove, and the store's owner, Jeong J. Park, also known as Sarah Park, 55, of La Mirada;

· La Moda XVII, Inc., doing business as Fashion Q in Baldwin Park; and

· NXT.G Corporation, doing business as Zzotta Shoes in the Pacific View Mall in Ventura, and the store's owner, Kyung Sook Jung, also known as Grace Lee.

All of the defendants named in the criminal informations will be issued summonses directing them to appear for arraignments in federal court in the coming weeks.

A criminal information contains allegations that a defendant has committed a crime. Every defendant is presumed innocent until and unless proven guilty in court.

All of the charges filed in Operation Fright Night are misdemeanor offenses that carry a statutory maximum penalty of one year in federal prison and fines of up to $100,000 for an individual and up to $200,000 for a corporation.

The California Department of Public Health today warned consumers against using decorative contact lenses without first consulting with an eye care professional (see:http://www.cdph.ca.gov/Pages/NR15-078.aspx).

The FDA has issued various warnings against the use of cosmetic contact lenses (for example:http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm402704.htm).

USAO – California, Central Updated October 26, 2015

Central District of California DOJ / 15-117 / October 23, 2015