On (b)(6) 2021, an eye care provider (ecp) in spain reported a patient (pt) was diagnosed with a corneal ulcer od in (b)(6) 2020 while wearing the acuvue® oasys® for astigmatism brand contact lens (cl).The pt experienced discomfort and redness after a period of cl wear.The pt sought medical attention (unknown date) and was diagnosed with a corneal ulcer od and prescribed tobradex eye drops (unknown frequency, dosage, duration).No further information was provided.On 19jan2021, additional information was provided by the reporting ecp.The pt was diagnosed with a ¿bacterial ulcer.¿ the issues began after 2-3 days of cl use.The pt did not notice any issues with the cl lenses.The ecp reported the pt has dry eyes and frequently uses artificial tears.The exact location of the ulcer is unknown.The pt has not returned to cl wear.The ecp reported the pt did not have any permanent damage or permanent loss of visual acuity.No further information was provided.On 20jan2021, additional information was provided by the reporting ecp.The pt was prescribed tobradex tid for 5 days.The ecp reported the pt has finished the treatment and currently feels fine.The location of the ulcer was inferior temporal.No further information was provided.On 27jan2021, additional information was provided by a representative of the reporting ecp.The medical report (date of visit not provided) from the treating ophthalmologist confirmed the pt was prescribed tobradex tid for 5 days.The diagnosis was od bacterial corneal ulcer located inferior temporal.The representative reported it was unclear if the bacteria was caused by the cl or by the pts hygiene or make-up.The pt recovered after 5 days with no further issues, no permanent damage, and no visual acuity problems.The pt has not returned for follow-up and it is unknown if the pt has returned to cl wear.No further information was provided.On 03feb2021, the reporting ecp representative clarified the pt provided the information from the medical report that the pt received from the treating ophthalmologist.The date of the visit was not provided.The treating ophthalmologist contact information is unknown.The pt has not returned for follow-up and no further medical information is expected.The suspect od cl has been discarded.A lot history review was performed and revealed the following: 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.Lot b00rc04 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.
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