MAR 2014

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/276058

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Page 147 of 210

"Also, aluminum has been demonstrated to be cytotoxic," Dr. Werner said. Dr. Werner then helped develop a test study on rabbits to investigate this hypothesis of cytotoxicity involving aluminum particulates, which was positively demonstrated. The result was that the washing fixtures were replaced with ceramic- coated stainless steel washing fix- t ures. "Ceramic coating is a very safe inorganic and biologically inactive material," Dr. Werner said. "The base of stainless steel material is already used in medical devices—even some glaucoma devices." Dr. Werner acknowledged that the test wasn't perfect, but it was an excellent test prior to human use. "The rabbit cornea is not similar to the human cornea," Dr. Werner said. "It's actually quite different. But the rabbit eye as a whole model has an exaggerated and accelerated inflam- matory reaction to different agents, so if you have a suspicion that an agent is going to cause some inflam- matory reaction in the eye, that's an absolutely excellent model to use to test." HOYA subsequently relaunched its IOLs and found no further problems. Hence, the problem was almost certainly a previous manufacturing issue, admittedly by the company. Subsequent to Dr. Werner's findings, HOYA changed the manufacturing process as described and relaunched its one-piece IOL platforms. At the time of ESCRS, minimally 3,000 to 5,000 lenses had been implanted, the company said, with no reports of subsequent problems. New one- piece intraocular stock was available in the summer of 2013 and at the end of September, sales in France and Germany recovered 40% and 70%, respectively, compared to what they were prior to the voluntary recall. This was a good sign about customers' trust in HOYA products, according to the company. Not picture perfect, but a good start Clearly, HOYA still has a dog in the fight of corporate transparency. It may well benefit the company to openly report that its manufactur- i ng issue has been firmly resolved in order to reassure customers that IOLs are now in good shape. HOYA's willingness to clearly go on the record and account for its a ctions is, in a word, new. E W Editors' note: Dr. Werner has financial interests with HOYA. Contact information Werner: liliana.werner@hsc.utah.edu EW International 145 www.ahmedvalve.com 800.832.5327 M arch 2014 144-148 International_EW March 2014-dl2_Layout 1 3/6/14 4:18 PM Page 145

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