B&L Recalls Some MultiPlus
B&L Recalls Some MultiPlus
Bausch & Lomb initiated a limited voluntary recall of 12 lots of ReNu MultiPlus lens care solution from distribution centers and retail shelves in the United States and other countries after an investigation of three customer reports of discolored solution. B&L said there were no reports of serious adverse events associated with these lots and believes virtually all of the affected product, manufactured about a year ago at its plant in Greenville, S.C., has already been used by consumers.
The root cause of the discoloration was an elevated level of trace iron in a single batch of raw material sourced from an outside supplier. Iron is an element present at trace levels — measured in parts per billion — in many compounds used in manufacturing food, drug, medical device and cosmetic products. An elevated level of trace iron may result in solution discoloration in some bottles, and the shelf life of the product may be shortened to less than its two-year expiration date due to a potential loss of effectiveness over time.
About 1 million bottles of solution from nine of the 12 lots were originally distributed in the United States. Product from the affected lots was also distributed in Canada, Latin America, Korea and Taiwan, and is also being recalled.
"We are confident we have identified the source of the problem and we are taking appropriate measures designed to avoid a recurrence," said Angela J. Panzarella, vice president and head of Bausch & Lomb’s global vision care business.
|For the Record
|On p. 26 of the February issue in the Contact Lens Care column, "Taking a Closer Look at Hydrogen Peroxide Products," by Susan Gromacki, OD, MS, FAAO, UltraCare (Advanced Medical Optics) is described as a three-bottle system that also includes Lens Plus Daily Cleaner and Lens Plus Sterile Saline. AMO sold the Lens Plus line to Inyx, Inc. in mid-2006. Contact Lens Spectrum regrets the error.|
CooperVision Launches Daily Disposable
CooperVision has officially introduced its Proclear 1-Day daily disposable contact lenses. Proclear 1-Day is manufactured in omafilcon A material with PC Technology, which CooperVision says keeps the lenses moist and comfortable throughout the day.
The lens features an aspheric optical design that blocks lens aberrations and theoretical corneal aberrations, according to CooperVision. The company also states that the optimized lens design and handling tint allow for easier application and removal and that the patented molded round edge reduces conjunctival interaction for better wearing comfort.
|■ Vistakon launched a national TV campaign in early March for its Acuvue Advance for Astigmatism contact lenses. The new TV spot focuses on night driving, one of the biggest problems reported by many astigmats because of blurriness and discomfort. The company has also launched www.beattheblur.com, an interactive consumer Web site that offers a self-diagnostic tool and an offer to receive a free trial pair certificate for Acuvue Advance for Astigmatism.|
■ CIBA Vision and Optometry Giving Sight have announced that Brian Spiller, currently Marketing Director for CIBA Vision Australia and New Zealand, has assumed the role of Optometry Giving Sight Corporate Fellow. He replaces Kristie Madara, who will resume her previous role at CIBA as Vice President — Global Corporate Communications.
■ Diversified Ophthalmics has announced the Platt Contact Lens Service, an independent, wholesale manufacturer of custom-made GP lenses, has joined the company’s contact lens team. Mr. Larry Platt will be based out of the company’s Southeast Division in Columbia, SC. Diversified also welcomes Bob Lawner, formerly president of Aero Contact Lens of Ohio.
■ 1–800 Contacts will close its ClearLab manufacturing operations in Plymouth, U.K. and consolidate operations in Singapore. The company anticipates a significant reduction in unit manufacturing costs as a result of the consolidation. It further expects to complete the U.K. site closure in the first quarter of 2007 and anticipates all manufacturing activity to be consolidated in Singapore by the end of the third quarter.
■ The Centers for Medicare and Medicaid Services granted New Technology Intraocular Lens designation to Bausch & Lomb’s SofPort Advanced Optics and SofPort Advanced Optics with Violet Shield Technology IOLs for their spherical aberration reducing design. The NTIOL designation means the Medicare reimbursement to ambulatory surgery centers for cataract surgery will increase by $50 when surgery is performed with one of the two SofPort IOLs designated.
■ The Alcon Research Institute Awards Symposium recently recognized its 2007 awardees for their outstanding research contributions to the field of ophthalmology. The 2007 recipients include Rando Allikmets, PhD, Dimitri Azar, MD, Paulus de Jong, MD, PhD, Paul Lee, MD, JD, James Pitzer Gills, III, MD, Joy Gills, Lois Smith, MD, PhD, and Bernhard H.F. Weber, PhD.
■ Insite Vision has granted Inspire Pharmaceuticals exclusive rights to commercialize AzaSite for ocular infection in the United States and Canada. AzaSite is a topical anti-infective treatment for bacterial conjunctivitis, which is currently under new drug approval review by the U.S. Food and Drug Administration. It contains the drug azithromycin and DuraSite, InSite’s patented drug delivery system.
■ The American Optometric Association has launched its Keeping Injuries Down in Sports (KIDS) state association grant programs, sponsored by Liberty Sport. The grants provide funding assistance for projects that support public education and awareness of the prevention of sports-related eye injuries through the use of appropriate personal protective eyewear. The official application and instructions are available at www.aoa.org/kids-grant.xml. The AOA will also offer its latest "New in Practice" courses at its meeting in Boston on June 30, 2007. The Panel of Expert series is designed for ODs who have been in practice for less than 10 years and is sponsored by a grant from CIBA Vision. Course topics include billing and coding, setting up an optical, financial management and new technologies in optometric care. Register at www.optometrysmeeting.org.
■ The World Council of Optometry will present Prof. Kovin Naidoo, the Global Director of the International Centre for Eyecare Education Africa, with the International Optometrist of the Year Award at its General Delegates Meeting this month. The WCO will also present Antonio Joson, Jr., currently the Secretary-General and regional Liaison for the Asian-Pacific region, with the Distinguished Service Award for his outstanding life-long international contributions.
Organizations Consider OD Board Certification
A Joint Board Certification Project Team has formed to explore a board certification process for Doctors of Optometry. The project team members were selected by their respective organizations, which include the American Optometric Association (AOA), the American Academy of Optometry (AAO), the Association of the Regulatory Boards of Optometry (ARBO), the National Board of Examiners in Optometry (NBEO), the Association of Schools and Colleges of Optometry (ASCO), and the American Optometric Student Association (ASOA).
The project team’s ultimate goal is a program that would be endorsed by optometric organizations and made available to optometrists who have a need to demonstrate continued and advanced clinical competence. In a joint statement the participating organizations say they’ve chosen to address board certification now because the profession has demonstrated a readiness to consider the issue in a comprehensive and inclusive manner.
The project team anticipates that the program development will take up to 24 months. Optometric organizations not included in the team are also invited to provide input. The end result will be an actual "product" that members can all evaluate and discuss. The team states that this attempt at a board certification process will not be like the unsuccessful American Board of Optometric Practice because this process will involve key optometric organizations working together to create the final product.
|STUDY EVALUATES SILICONE HYDROGELS AND LENS CARE
|Silicone hydrogel wearers in a recent clinical study of multipurpose solutions reported that Clear Care (CIBA Vision) was easy to use and that it provided better cleaning, clarity of vision and overall comfort compared to the leading multipurpose solutions.|
The CIBA Vision-sponsored study compared the clinical performance of Clear Care to leading multipurpose solutions for silicone hydrogel lenses. Investigators were private practitioners at 12 different sites. The 187 subjects were MPS users, wearing silicone hydrogels on a daily wear basis. During the 30-day Fall 2006 study, primary variables such as corneal staining and subjective ratings were evaluated. The study compared Clear Care to Opti-Free Replenish (Alcon), Opti-Free Express (Alcon), Complete MoisturePlus (Advanced Medical Optics) and ReNu MultiPlus (Bausch & Lomb) as a group. Study participants were current wearers of O2Optix (CIBA Vision), PureVision (Bausch & Lomb), Acuvue Advance or Acuvue Oasys (both Vistakon) silicone hydrogel lenses.
The subjects in this study also reported that Clear Care was superior for comfort at insertion, end-of-day comfort and for preventing irritation at the end of the day.
CIBA Discusses Industry, O2Optix
At the recent SECO International meeting in Atlanta in February, CIBA Vision held a media briefing in which it presented marketing data on the contact lens industry as well as an update on the O2Optix supply constraints and backorders that resulted from the early 2007 partial recall.
The company announced that it has almost completed construction of a manufacturing facility in Johor, Malaysia that will be almost entirely dedicated to producing O2Optix contact lenses. The company expects supply constraints and backorders into the second quarter with increasing improvements through mid-year. CIBA also stated that its new O2Optix Custom lens is manufactured on a different platform and is completely unaffected by the partial recall of O2Optix.
Among the contact lens industry data presented, CIBA reported that in 2006 the contact lens market grew overall in the United States, Europe and Japan, with silicone hydrogel lenses experiencing the most growth, up as much as 72 percent in the United States. Silicone hydrogels represented 39 percent of contact lens revenues in the United States last year.
Data on contact lens wearers reveals that many patients drop out of lens wear at about age 45, due primarily to presbyopia. In addition, patients tend to be successful with contact lens wear or good candidates for wear when they have moderate to severe vision correction needs. Patients enter contact lens wear mainly for appearance and convenience, followed by discomfort of eyeglasses, better vision and active lifestyle. Although about 66 percent of patient admitted to accidentally napping or sleeping while wearing their lenses at least once per month, more than half of surveyed lens wearers did not want to wear lenses overnight.
The top two reasons why lens wearers drop out continues to be dryness complaints and end-of-day discomfort, followed by eyes getting tired, eyes feeling irritated during lens wear and hazy/blurry vision. Finally, CIBA reported that 73 percent of eyeglass wearers aged 18 to 39 who’ve never worn contact lenses before have also never discussed lens wear with their eyecare practitioners, representing a large potential market for lens wear.
|SECO International 2007 Awards
|SECO International held its 84th annual meeting from Feb. 21–27, which was was attended by approximately 8,000 optometrists, opticians, certified ophthalmic technicians and paraoptometric professionals from around the world. In addition to providing more than 385 hours of continuing education and more than 240 technical exhibits, SECO International also presented the following awards:|
- Optometrist of the South: Tom Griffith, OD
- Young Optometrist of the South: Susanne S. Cunningham, OD
- Paraoptometric of the South: Kathy A. Disner
CE Conference Report Released
The Association of the Regulatory Boards of Optometry recently released its report from the National Optometric Continuing Education Conference (NOCEC), which took place from May 13–14, 2006. According to ARBO, the mission of the NOCEC was to develop a profession-wide, consensus-driven approach to the future of continuing education and optometric competence for the benefit of the public.
The final summary reported that attendees showed interest in renewing dialogue involving all stakeholders to reassess continued competence and board certification topics. Attendees also were critical about the efficacy of the current unstructured continuing education system in assuring and maintaining competencies, and they addressed the issues involved with commercial support of continuing education.
|Vistakon Names Director of Professional Affairs
|Carol Alexander, OD, FAAO, has joined Vistakon as Director, Professional Affairs. She will begin her transition to Vistakon in July. Dr. Alexander is a private practitioner with more than 20 years in practice. She is a past president of the Ohio Optometric Association and has also served on several national AOA committees in the areas of regulation and legislation.|
|JURY AWARDS J&J DAMAGES IN LAWSUIT
|In late February a jury in a U.S. district court in New York City determined that CIBA Vision willfully engaged in false advertising and promotion to eyecare professionals about its O2Optix contact lenses, according to Vistakon. CIBA falsely claimed in its professional materials that 90 Dk/t is a critical minimum level for the avoidance of severe hypoxic stress in daily wear contact lenses, according to a lawsuit filed in September 2004 by Johnson & Johnson Vision Care, Inc. Vistakon also reports that the jury found that CIBA deliberately offered misleading description and representation of the Acuvue brand in its professional advertising and promotional materials. CIBA corrected the advertising in late 2004.|
A statement from CIBA Vision indicates that the company is pleased with the outcome of this lawsuit, which sought financial recovery from the earlier 2004 lawsuit. According to CIBA, J&J was awarded about $150,000 in damages when it had requested about $7 million, and the jury also denied J&J any award of attorneys’ fees.
Contact Lens Spectrum, Issue: April 2007