On (b)(6) 2018, an email was received from an eye care professional (ecp).The email contained an attached summary data spreadsheet containing the medical information for subjects involved in the study of acanthamoeba keratitis conducted in the (b)(6).The information received from the ecp included only those study subjects who reported wearing acuvue brand products at the time of the adverse event.All the study subjects were initially examined and diagnosed with acanthamoeba keratitis during 2011-2014.The patient (pt), study id (b)(6), presented to the hospital on (b)(6) 2013 with severe photophobia, redness, pain and swelling and diagnosed with acanthamoeba keratitis os.The pt reported wearing the oasys brand contact lenses at the time of the event and using optifree express solution.The pt reported sleeping in the lenses for 6 nights/year, 1 night in a row and was treated with antiamoebics for 1 month.Va: 6/6 (20/20).No additional information is expected to be received.The lot number of the suspect product is unknown.The suspect product is not available for return for evaluation.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.
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