The reporter stated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens in the patient's right eye (od) on (b)(6) 2014.The reporter stated the patient has a refractive surprise.The lens is 20/40 -1.00, the lens vault is 350um, intraocular pressure is mid-teens and eyes are only mildly dry.The lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
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Method: medical review.Results: per medical review - reportedly, by a person from the facility, following immediate icl implantation the patient did not achieve uncorrected visual acuity she was expecting.The iop was not elevated.At the five-week follow-up , email was received from the same person from the facility, stating that patient status improved and va was 20/20 uncorrected.According to that email the most likely cause of the event was not device related.The event was caused by medication (unknown artificial tears).Upon the patient stopped taking artificial tears, the visual acuity improved.It is well known that some artificial tears may cause blurred vision.She was very happy with the results.Conclusions: based on the complaint history, work order search and the medical review, the event was caused by medication (unknown artificial tears) (b)(4).
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