Contact lens users who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately. Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-877-884-7779 Monday through Friday between 8 a.m. and 5 p.m. Eastern Time or visit www.amo-inc.com for instructions. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-877-884-7779 Monday through Friday from 8 a.m. through 5 p.m. Eastern Time for more information. Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by calling 1-calling 1-800-347-5005 and to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch. Product from the recalled lots was distributed nationwide to food, drug and mass merchandiser accounts. The recall does not include 4-ounce and 16-ounce bottles, or professional samples and packs provided to eye care practitioners. The U.S. recall includes approximately 183,000 units, representing less than one percent of COMPLETE® MoisturePLUS(TM) contact lens products distributed in the U.S. on an annual basis. Based on its investigation to date, AMO believes the likelihood of users experiencing an adverse reaction is low. However, the company is taking a conservative approach and is conducting the recall in the best interest of its customers. The company commenced the investigation after testing of products sold in Japan determined that three production lots were found to be non-sterile and contaminated with bacteria. As a result, AMO conducted a limited product withdrawal in Japan and notified appropriate global regulatory authorities, including the FDA. The subsequent investigation traced the manufacturing issue to two of the four production lines in its China facility that manufactured product during a specific period. This product was shipped to the U.S. , Japan and Asia Pacific and is now the subject of this recall. AMO has temporarily ceased all manufacturing at the China facility and scheduled a special cleaning and sanitation of the manufacturing areas and all applicable equipment. Products manufactured in AMO's facility in Spain, which produces the vast majority of AMO's contact lens solution products distributed in the U.S. and Europe, are not affected by this recall. "AMO is committed to taking all necessary measures to remedy this production-line issue and protect the trust physicians and patients place in our products," said Randy Meier, executive vice president, operations; president, global eye care and chief financial officer. "COMPLETE® MoisturePLUS(TM) products have been used safely by millions of contact lens wearers since their introduction in 2003 and are supported by our 50-year heritage of meeting high safety and efficacy standards."
Ennis & Ennis, P.A. is representing individuals that have experienced an eye infection during or after use of Bausch & Lomb ReNu MoistureLoc Saline Solution. If you or a loved one have used Bausch & Lomb saline solution you may be entitled to compensation. Click here for a free, confidential case evaluation. Washington DC Office 1101 Pennsylvania Ave. Suite 600 Washington DC 20004 Telephone: 202-756-2972 Miami Office 1111 Brickell Avenue 11th Floor Miami, FL 33131 Telephone: 305-913-7199 Fort Lauderdale Office 110 E. Broward Blvd. Suite 1700 Fort Lauderdale, FL 33301 Telephone: 954-315-3934 Facsimile: 954-315-3914
Free Case Evaluation. Nationwide: 1-800-856-6405 |
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