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Article Date: 6/1/2007

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Recalls: Companies Focus on Product Safety
contact lens care

Recalls: Companies Focus on Product Safety

BY SUSAN J. GROMACKI, OD, MS, FAAO

Mistakes happen all the time — at the grocery store, restaurant, bank — in every facet of our daily lives. Even All-Star baseball players make errors in the field. We're human after all.

When mistakes occur in health care, however, more serious consequences can result. That's why we as practitioners take special note when one of the products we prescribe is recalled or removed from the market.

The contact lens industry takes these recalls seriously for the same reason that we do: the health of our patients. The industry also has the additional motivation to avoid lost revenue both from the disposed solution and from negative publicity surrounding the recalls.

Companies have to be responsible not only to patients, but also to practitioners and shareholders. It benefits them, for every reason, to provide the best, safest product possible.

A Recall Review

In the past year and a half, there were more contact lens solution recalls and production stoppages than in any comparable period in history. Alcon has been the only major manufacturer without a solution issue, but it did experience a recall with Systane Free artificial tears.

Here's a review of recalls over the last two years.

March 6, 2007: ReNu MultiPlus (Bausch & Lomb) B&L recalled 12 lots due to an elevated level of trace iron. This could discolor the solution and lead to decreased shelf life.

Most of the solution was manufactured a year prior and had already been used by patients without consequences.

It's important to note that all of these recalls were voluntary.

Nov. 21, 2006: Complete MoisturePlus (Advanced Medical Optics) AMO recalled 18 lots due to known bacterial contamination of three lots sold in Japan.

May 15, 2006: ReNu with MoistureLoc (Bausch & Lomb) The solution was permanently removed from the marketplace due to its presumed association with an outbreak of Fusarium keratitis in the United States and Asia.

Fourth quarter 2005: CIBA Vision The company suspended production of its lens care product lines as a "cautionary measure in response to concerns about the manufacturing process." No products were shipped that did not meet their requirements.

On March 31, 2006, shipment of AOSept and Clear Care resumed, followed by Aquify, Miraflow, Aquify Long-Lasting Comfort Drops and SoftWear saline.

A Safe Product

People from patients to colleagues to Wall Street analysts have asked me, "Is there reason for concern regarding the safety of the existing supply of solution or the future of the contact lens industry?" No to both.

The recalls ensure that we have safe product. Of course, it's discouraging for patients when their solution is unavailable for purchase.

The contact lens industry is alive and well and will continue to be in the future. It's important to note that all of these recalls were voluntary — not mandated by the FDA, Centers for Disease Control and Prevention or anyone else. It proves that these companies are willing to take measures to protect our patients that may temporarily affect their good reputations. CLS


Dr. Gromacki is a Diplomate in Cornea and Contact Lenses in the American Academy of Optometry. She has a specialty contact lens and post-surgical co-management practice as part of a multi-subspecialty ophthalmology group in Ann Arbor, MI.



Contact Lens Spectrum, Issue: June 2007

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