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November 1991

Discoloration of a Silicone Intraocular Lens 6 Weeks After Surgery-Reply

Author Affiliations

Irvine, Calif

Arch Ophthalmol. 1991;109(11):1494-1495. doi:10.1001/archopht.1991.01080110028015

In Reply.  —This letter is in response to Dr Watt's letter concerning discoloration of an IOL model SI-18NGB manufactured by Allergan Medical Optics (AMO), Irvine, Calif. We appreciate the opportunity to address Dr Watt's concerns and will be sending a clinical researcher to observe this lens firsthand. In the meantime, we have consulted the manufacturing records of this IOL and found that 34 other lenses from the same batch have been implanted with no report of discoloration.Dr Watt's description of a centrally located discoloration appears similar to our observations made during Food and Drug Administration core studies in 1987. Several investigators reported that under slit-lamp examination, eight subjects (1.6%) in the cohort were found to have a slight haze in the center of their SI-18B implant. However, all three investigators believed this haze to be clinically insignificant and noted no visual disturbance. In addition, all three investigators noted that

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