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—STAAR Surgical first learned of Dr Milauskas's reported observations on April 9, 1991, at the American Society of Cataract and Refractive Surgery meeting in Boston, Mass. We immediately initiated an exhaustive quality assurance review of the manufacturing lots from which the subject lenses were made. The results of the review of the manufacturing records for these lenses were unremarkable, with the specifications for the RMX-3 silicone material found to be acceptable. A total of 6874 IOLs made from the same RMX-3 material lots have been implanted, with no other reports of brown colorization.We consulted two materials scientists who pointed out that silicones are the materials of choice for many applications in which resistance to extremes of chemical, temperature, and UV light exposure is necessary. They do not dry out, become brittle, or discolor with age. In fact, the primary use of the RMX-3 silicone material in industry
Ziemba SL. Silicone Intraocular Lens Implant Discoloration in Humans-Reply. Arch Ophthalmol. 1991;109(7):914–915. doi:10.1001/archopht.1991.01080070023008
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