This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Device evaluation - product evaluation found that the lens was returned in liquid, with clear surgical residue/debris on the product, and in the lens case/vial.Visual inspection found the haptic broken with dried, discolored material on the lens surface.(b)(4).
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The reporter indicated that a 12.1mm vticmo12.1 implantable collamer lens, had cracked just when the lens was coming out from the injector.This occurred on (b)(6) 2016, before injecting into the left eye (os).The lens was not implanted and there is no reported patient injury.This lens has been returned and evaluated.
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