On (b)(6) 2013, our firm received an email from a patient's (pt) spouse reporting the pt experienced acanthamoeba keratitis ou while wearing acuvue oasys contact lenses (cl) and was being considered for corneal transplant in one or both eyes.The pt wore the lenses on a daily wear schedule, the replacement schedule was not reported.Mdr number 1033553-2014-00002 submitted for the od.On (b)(6) 2013, we spoke with the pt's spouse who stated the pt was seen by a doctor for the first time on (b)(6) 2013 and dx with acanthamoeba on (b)(6) 2013.He stated the pt didn't "have vision in either eye." cultures of both eyes were performed, testing positive for acanthamoeba.The pt's spouse stated they were in florida when the symptoms occurred and that the pt had been in a pool but her head wasn't submerged in the water.He also stated that the pt had showered while wearing cl.On (b)(6) 2014, the ecp's stated the pt was in surgery but no details were provided.On (b)(6) 2014, the pt's husband stated the pt received a corneal transplant os on (b)(6) 2014; the od is not scheduled for a transplant at this time.Medical records were received on (b)(6) 2014.Additional information will be submitted within 30 days of receipt.Fourteen sealed blister were returned.The parameters were measured and a visual inspection was performed.The lenses meet company standards for base curve, center thickness and diameter.No other visual attributes were observed.The solution was also tested.The ph and conductivity were in specification.A device history review was performed.The batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.
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