Consumers Who Purchase Contact Lenses Online Face Greater Eye Health Risks

New York NY, 01-13-2008 A  study reported in the January issue of Optometry: Journal of the American Optometric Association, indicates that internet lens purchasers typically don't follow their eye doctor's recommendations, potentially placing them at greater risk for harmful eye care practices and eye health complications. The research was conducted by Joshua Fogel, Ph.D., and Chaya Zidile of Brooklyn College. The study included 151 students from the university who were contact lens wearers.
     The findings indicated that online and store purchasers (consumers who get their contacts at a wholesale club or optical chain outlet) are less likely to adhere to healthy eye care practices, as recommended by their eye doctor. "We found that a pattern exists regarding the method of contact lens purchasing and following recommendations from the Food and Drug Administration (FDA)," said Dr. Fogel. "Those who bought contact lenses at their doctor's office followed a number of FDA recommendations more so than those who bought contact lenses elsewhere."
     The study, which researched the purchasing and eye care behaviors of contact lens wearers, found that 86 percent of individuals who purchased their lenses from an eye doctor received a yearly comprehensive eye examination. But, only 76.5 percent of those individuals who purchased their lenses via the Internet saw an eye doctor on a routine basis. Also, despite potential uncomfortable side effects, 35 percent of online purchasers did not check that the order matched their prescription.
     One of the largest discrepancies found between in-office and out-of-office contact lens purchases was seen in the number of individuals who saw an eye doctor for a follow-up appointment to ensure the proper fit of their lenses. Fifty-seven percent of individuals who purchased their lenses from an eye doctor went in for a follow-up appointment, as compared to only 29 percent of online purchasers.
(Thank you to Contact Lenses Today® and the staff of Contact Lens Spectrum.)

American Academy of Ophthalmology Warns Consumers about Decorative Contacts

San Francisco CA,  10-14-2007  The American Academy of Ophthalmology issued a reminder to consumers that serious eye disorders can be caused by over-the-counter lenses. In the statement the Academy noted that those most likely to buy decorative contacts—teens and young adults—are also most likely to be unaware of the risks these devices can pose to their eyes and life-long visual health.
     Although over-the-counter sales of nonprescription "plano" cosmetic lenses have been illegal in the United States since 2005, decorative contacts are still widely available in retail stores and on the Internet. They are especially popular at Halloween as accessories to costumes. Because consumers buying over-the-counter are not educated on proper use and care of decorative contacts, they do not realize the harm that can result from improper use.
     The Academy suggested that consumers go to www.geteyesmart.org, the Academy's public website for more information about cosmetic lenses.

NAD Recommends Bausch & Lomb Discontinue Claims for ReNu MultiPlus

New York, NY.,  10-14-2007  The National Advertising Division (NAD) of the Council of Better Business Bureaus, one of the investigative arms of the advertising industry’s voluntary self-regulation program, has recommended that Bausch & Lomb, Inc. discontinue claims that suggest that ReNu MultiPlus Solution is the top-selling or most "trusted" among contact lens wearers. The advertising claims made by B&L were challenged by Alcon Laboratories, Inc., maker of Opti-Free Express.
     Specifically, the following claims were challenged: "ReNu MultiPlus Solution is a solution for soft contact lenses. It is the #1 selling Multi-purpose formula in the U.S." and ReNu MultiPlus "has been trusted by over 20 million contact lens wearers and their eye care professionals."
     In its decision, NAD noted that it is undisputed that Alcon’s Opti-Free Express is currently the leading selling manufacturer brand of multi-purpose solution in the U.S. market, however, nothing in its decision precludes B&L from making an expressly qualified claim that the formula sold under the brand name ReNu MultiPlus together with the same formula as private label store brands is the #1 selling contact lens formula in the United States.
     NAD also concluded that the evidence was not sufficient to support the advertiser’s claim that ReNu MultiPlus "has been trusted by over 20 million contact lens wearers and their eye care professionals."
     Bausch and Lomb in its advertiser’s statement said that while it is "disappointed by NAD’s finding that the selection and use by consumers of a medical device does not equate with consumer trust of the product, Bausch & Lomb will be guided by NAD’s recommendations in its future advertising."

FDA Concerned Patients May Still be Using Complete MoisturePlus

Washington, DC.,  08-05-2007  On August 1, the U.S Food and Drug Administration (FDA) announced that many consumers might not be aware of the May 2007 recall of Advanced Medical Optics' (AMO) Complete MoisturePlus multipurpose contact lens solution and continue to use the recalled product. Following the recall announcement, it says several cases of Acanthamoeba keratitis have been reported to the Centers for Disease Control and Prevention (CDC) that involve use of the solution. The agency said that individuals who wear soft contact lenses should immediately stop using the product and discard all remaining solution, including partially used or unopened bottles. For additional information and recommendations, see the FDA Preliminary Public Health Notification, May 31, 2007 at http://www.fda.gov/cdrh/safety/053107-acanthamoeba.html.

AMO Recalls Complete MoisturePlus MPS

New York, NY.,  05-29-2007    Late Friday evening, Advanced Medical Optics (AMO) announced an immediate voluntary recall of its Complete MoisturePlus (CMP) multipurpose contact lens solution (MPS) after data from the Centers for Disease Control (CDC) showed the risk of developing Acanthamoeba keratitis (AK) was at least seven times greater for patients who used AMO CMP. No single lot number was repeated, suggesting that AMO CMP was not intrinsically contaminated.
    In Jan. 2007, the CDC initiated a retrospective survey of 22 ophthalmology centers nationwide to assess whether cases of AK were increasing in the U.S. In March 2007, data from 13 centers demonstrated an increase in culture-confirmed cases of AK with wide geographic distribution. On March 16, the CDC initiated a multi-state investigation to look for risk factors associated with the increase in AK cases. The report indicated an association with AK in soft contact lens wearers who had used AMO CMP solution. The CDC has received reports of 138 cases of culture-confirmed AK in 35 states and Puerto Rico, with complete patient data available for 46 case-patients.
    Lab testing is ongoing, but an initial analysis was conducted using data from the first 46 completed patient interviews. Among the 46 culture-confirmed patients interviewed, 59% (27) were female, 85% (39) wore soft contact lenses. In addition, 38% (16) reported swimming and 83% (35) reported showering while wearing their contact lenses. Of the 39 patients for whom clinical data was available, 36 reported using one or more specific types of contact lens solution, 21 (58%) reported some use of AMO CMP in the month before onset of symptoms, 20 (56%) reported using AMO CMP as their primary solution and 14 (39%) reported using AMO CMP exclusively. The CDC notes that although the results of the initial analysis are preliminary, they suggest that use of AMO CMP increases the risk for AK.    

B&L Suspends ReNu Shipments in U.S.

New York, NY.,  04-12-2006    Bausch & Lomb (B&L) voluntarily suspended U.S. shipments of ReNu with MoistureLoc lens care solutions, following an alert from the Centers for Disease Control (CDC) and Food and Drug Administration yesterday. The alert concerns an increasing number of Fusarium keratitis infections reported in the U.S. The CDC, FDA and local health departments are involved in an ongoing investigation to determine the source. As of April 9th, a total of 109 patients were under investigation in Calif., Conn., Fla., Ga., Iowa, Md., Mass., Mich., Miss., N.J., N.Y., N.D., Ohio, Pa., Tenn., Texas and Vt.
    The FDA says of the 30 cases investigated so far, 28 wore soft contact lenses. In the contact lens group, 26 (93%) remembered which solution they were using and all of them (100%) reported using a ReNu brand solution or a generic equivalent manufactured by the company. Five patients (18%) reported using other solutions in addition to ReNu, including some manufactured by Advanced Medical Optics (AMO) and Alcon. Nine admitted to wearing lenses overnight. However, no cause has been established.
    B&L is working closely with the CDC and the Wilmer Eye Institute of Johns Hopkins University to implement a multi-center surveillance program to establish the actual incidence. The company will also change its recommendation for replacing lens cases from once every three months to once per month, and stresses the importance of proper lens cleaning and care.
    The CDC advises clinicians who notice signs and symptoms of keratitis to consider the possibility of infection and obtaining a clinical specimen before initiating treatment. Report cases of Fusarium keratitis to state and local departments or directly to the CDC.      B & L Letter to Practitioners               AMO Letter to Practitioners                 

Below you will find the link to the federal Department of Health and Human Services CDC report: http://www.cdc.gov/mmwr/pdf/wk/mm55d410.pdf

B&L Sues Ocular Sciences, Charging Patent Infringement on Toric CLs

ROCHESTER, N.Y.-Bausch & Lomb (B&L) filed suit against Ocular Sci­ences in U.S. District Court for the Western District of New York here on October 5, charging patient infringement.
The suit relates to Ocular's Bio­medics toric soft contact lens and its private-label equivalent, used to correct astigmatism. Bausch & Lomb's suit charged that the Ocular lenses infringe on the patent for Bausch & Lomb's SofLens66 Toric CL.
In its suit, B&L asked the court for injunctive relief to require Ocu­lar to discontinue manufacturing
and sales in the U.S. of its alleged­ly infringing toric lens until the Bausch & Lomb patent expires in 2018, plus unspecified monetary damages.
"We believe this lawsuit is without merit, and we plan to conduct a vigor­ous defense," said Stephen Fanning, Ocular's president and chief executive officer. "We have been in discussion with Bausch & Lomb on this matter since January 2004, have investigat­ed the matter in detail, and believe that our patented Biomedics toric soft CL and the private-label equivalent do not infringe the B&L patent."

Bausch & Lomb and CIBA Vision reached a final settlement

ROCHESTER, N.Y. , 08-01-2004 Bausch & Lomb (B&L) and CIBA Vision, the eyecare unit of Novartis,
reached a final settlement last month resolving long-standing disputes between the two companies  in patent infringement lawsuits related to silicone hydrogel contact-lens materials.
Under the new agreement, B&L and CIBA have agreed to cross-license rights to their silicone hydrogel CL technologies. B&L will pay CIBA Vision a royalty on U.S. sales of its PureVision lenses until 2014, and on sales outside the U.S. until 2016.
The 30-day extended-wear PureVision CLs have been off the market in the U.S. since June 2002 because of the patent dispute. Following a ruling at that time, B&L transferred manufacturing and shipping of its PureVision lenses to its facility in Waterford, Ireland, and continued to sell the CLs outside the U.S. from there.
The pact between the two firms resolves patent lawsuits in U.S. district courts in Georgia, Delaware, and New York, as well as other suits and patent proceedings in Germany, Ireland, the European Patent Office, and Australia.
B&L can resume U.S. sales and manufacture of Pure Vision CLs on April 27, 2005, upon expiration of the patent that was the subject of a 2002 ruling in the Federal district court in Delaware; its Pure Vision lenses will continue to be available outside the U.S. CIBA Vision's Focus Night & Day CLs continue to be available worldwide.
"While the process that led to this settlement was a long one, both CIBA Vision and Bausch & Lomb believe the settlement is in the best interests of eye care professionals and consumers around the world," said Andrea Saia, president of CIBA Vision's global lens business.
Added Angela Panzarella, B&L's corporate vice president-global vision care, "This agreement allows us to focus our efforts on expanding our strong market position and continue development of new advances in silicone hydrogel materials."

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