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Staar Surgical Visian ICL

This article was originally published in The Gray Sheet

Executive Summary

Implantable contact lens PMA approval for myopia likely will be delayed beyond the Oct. 22 American Academy of Ophthalmologists meeting, the firm says, following Sept. 23 receipt of 36 "FDA 483" observations stemming from a re-inspection of its Monrovia, Calif. manufacturing facility. An initial inspection led to a December 2003 warning letter and subsequent Staar corrections. Current observations include quality system and complaint handling issues. Staar is preparing a written response and will undertake further corrective action (1"The Gray Sheet" Sept. 20, 2004, p. 3)...
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