The reporter indicated that the surgeon implanted a 12.6 mm vticmo12.6, -15/1.5/79 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was exchanged for a shorter lens due to observation of excessive vault.This exchange resolved the problem.
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Additional information: device evaluation: lens was returned dry in a micro-centrifuge vial with clear surgical residue on product.Visual inspection found the haptic torn and deformed, with foreign material (residue) on lens surface.Lens haptic was caught in vial cap.Corrected data: the reporter indicated that the surgeon implanted a 12.6mm vticmo_12.6, -15/1.5/79 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018, the lens was explanted due to excessive vault.A shorter replacement lens was implanted post-operatively on (b)(6) 2018 to resolve the issue.(b)(4).
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