|Trade Name||INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS|
|Classification Name||implant, corneal, refractive|
|Docket Number|| 99M-1167|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
This device is indicated for the reduction or elimination of mild myopia (-2. 00 to -3. 00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0. 50d for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1. 00d or less.
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