On 18oct2021 a johnson and johnson sales representative in (b)(6) called to report a patient (pt) was diagnosed with an od corneal infection at an eye clinic while wearing the 1-day acuvue® trueye® brand contact lens (cls).The pt was referred to the hospital for treatment.Nothing unusual was noted in the appearance of the suspect od cls.On 18oct2021 a call was placed to the pts treating ecp office.A representative at the ecp¿s office advised the pt was seen on (b)(6) 2021.No additional medical information was provided.On 19oct2021 additional information was provided by the pts treating ecp.On (b)(6) 2021 the pt presented to the clinic and was diagnosed with an infective corneal ulcer and iritis od.Focal site: center: size, about 2mm; infectiveness: positive.Va was not measured.The pt was prescribed tarvid eye ointment and bestron for ophthalmic.On (b)(6) 2021 the pt presented for follow-up (fu).The pt was prescribed vigamox ophthalmic solution as an additional prescription.On (b)(6) 2021 the pt returned for fu.No effect of the eye drop treatment was shown, the ecp referred the pt to the hospital on (b)(6) 2021.The pt reported experiencing pain od and continued cls wear during a round of golf.The outcome is unknown.On 31oct2021 additional information was provided by the ecp at the eye clinic.The pt replaces the cls daily.It is unknown how many hours daily the pt wears the lenses.(b)(6) 2021: the pt presented to the eye clinic with complaints of od pain.Diagnosis: keratitis, iritis, corneal erosion od; infectiveness: positive; culture was not conducted.Focal site: central cornea; size: slightly larger than 2 mm; findings: inflammation and opacity was noted in the center of the cornea; va: affected; corrected vision od: not measured; treatment: tarvid eye ointment, bestron for ophthalmic, mydrin; the pt was instructed to discontinue cls wear.The pt was requested to return for follow-up in the evening of (b)(6) 2021 (b)(6) 2021 fu: outcome: worsening; ecp findings: inflammation got worse and endophthalmitis increased; va: not measured; outcome: worsening; treatment: vigamox ophthalmic solution and flomax tablets were added; pt to continue no cls wear.The pt was instructed to return on (b)(6) 2021.(b)(6) 2021 fu: outcome: worsening; ecp findings: deteriorated further; va: not measured; treatment: no change; pt to continue no cls wear; the pt was instructed to return on (b)(6) 2021.(b)(6) 2021 fu: outcome: worsening; ecp findings: no improvement was noted.The ecp referred the pt to the hospital.At the 1st visit of the hospital, infectiveness was negative as a result of culture.Suspected gram-negative bacterium in clinical finding.Slightly improving with treatment of cravit ophthalmic solution 1.5%, tobracin ophthalmic solution, and tarivid eye ointment: date: (b)(6) 2021.(b)(6) 2021 ecp (b)(6) 2021: outcome: recovery.No additional medical information has been received.The lot number of the suspect product is unknown.The suspect od cls was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.
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On 20dec2021, additional information was provided from the japan affiliate.The lot number previously reported as unknown is updated as 4982730104 for the suspect product, 1-day acuvue® trueye® brand contact lens (cls).No additional information was provided.Lot history review in progress.If any further relevant information is received, a supplemental report will be filed.
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