JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE; LENSES, SOFT CONTACT, DAILY WEAR
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Catalog Number 1D2 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Keratitis (1944); Acanthameba Keratitis (1945)
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Event Type
Injury
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Manufacturer Narrative
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Nicole carnt, jeremy hoffman, seema verma, cherry radford, darwin c.Minassian and john k.G.Dart: acanthamoeba keratitis: confirmation of a current uk outbreak and a prospective case control study identifying contributing risk factors.(b)(4).
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Event Description
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On (b)(6) 2018, an email was received from an eye care professional (ecp).The ecp is the author of a prospective study, conducted in the uk, that has been submitted for publication in 2018.The email contained an attached summary data spreadsheet containing the medical information for subjects involved in the prospective acanthamoeba keratitis study.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), (b)(6), was initially diagnosed with hsv keratitis os and treated with topical steroids and antibiotics.The pt was referred to the hospital on (b)(6) 2012.The pt reported wearing 1 day acuvue brand contact lenses.The daily lenses worn by the pt were two months old.The pt also reported using water to clean the lens case and not washing their hands prior to handling lenses.The pt was diagnosed with acanthamoeba keratitis and treated with antiamoebics (phmb and hexamidine) for nine months in addition to topical steroids after being diagnosed.Va 6/6 (20/20).No additional information is expected to be received.The lot number of the suspect product is unknown.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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Search Alerts/Recalls
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