On (b)(6) 2021 a patient (pt) in (b)(6) advised there is no ¿inside out mark on lens¿ for the acuvue® vita¿ brand contact lens (cl).On 21feb2021 the pt provided additional information.The pt advised there is no visible mark on the lens when opening the blister on (b)(6) 2021.The pt attempted to wear the suspect lenses in both eyes and experienced discomfort and blurry vision after 1 hour of wear.The pt continued to experience discomfort after the suspect after removing the suspect lenses ou.The pt didn¿t seek any medical attention.On 22feb2021 the pt provided additional information.The pt did not experience blurry vision, only discomfort ou on removal of the suspect cls.The pt will ¿see a doctor later in regard to the eye condition¿.On (b)(6) 2021 the pt will seek medical attention soon and will call to provide additional information.On 01mar2021 the pt reported an eye care provider (ecp) on (b)(6) 2021 and will return to the ecp in mar2021.The pt will provide information after the 2nd visit to the hospital.On 04mar2021 the pt advised that the doctor diagnosed ¿eye inflammation due to wear cls.¿ the pt ¿applied 2 eye drops¿ but couldn¿t remember the name of the drops.The pt will follow-up with the ecp ¿after the eyes get better.¿ no additional medical information was received after multiple attempts.On 27jan2022 the pt provided the medical report for the ecp visits in 2021.Date if visit: (b)(6) 2021 ¿ eye hospital.Chief complaint: discomfort in both eyes after wearing contact lenses for 10 days, wear contact lenses for 11-12 hours every day.Exam: uncorrected vision: od: 0.2, os: 0.25.Corrected vision: od: 0.6, os: 0.8-; iop: od: 24.5 mmhg, os: 21.4mmhg.The eye exam reflects conjunctival congestion, corneal opacity, fl(+).Diagnosis: binocular conjunctivitis.Prescribed levofloxacin eye drops and recombinant bovine basic fibroblast growth factor in eye drop.The pt was advised to stop wearing contact lenses for 2 weeks.Date of visit: (b)(6) 2021 follow-up visit.Exam: uncorrected vision: od: 0.15, os: 0.12.Corrected vision: od: 0.4, os: 0.8-; iop: od:21 mmhg, os: 20.3mmhg.Bcva: od: -5.50/ - 1.00 x 180 1.0, os: -5.50 / - 1.25 x 5¿1.0.Diagnosis: binocular myopia and visual fatigue.On 27jan2022, the event was determined as a serious medical reportable event with the addition of the pts medical reports.On (b)(6) 2022 the pt advised the eyes were getting much better now and the vision is fine.The pt couldn't recall any additional information regarding the corneal opacity.The pt reported the previous eye drops were applied three times daily and 1 drop at a time.No additional medical information was provided.Multiple additional calls were placed to the pt for additional product and medical information, but nothing additional has been received.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 b00vhq3 was produced under normal conditions.Corneal opacity is being reported in the pts the od as we were unable to verify from the medical report which was the affected eye.It is unknown if the suspect od cl is available for return for evaluation.No additional evaluation can be conducted.This report is for the pts od event.The report for the pts os will be submitted in a separate report.If any further relevant information is received, a supplemental report will be filed.
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