On (b)(6) 2019, a patient (pt) in (b)(6) reported headache, redness, pain, swelling, and pressure while wearing the acuvue® oasys® for astigmatism brand contact lenses (cls) in the os on (b)(6) 2019.The pt¿s os was red upon removal of the suspect cl.The pt did not seek medical attention.The pt reported using saline to clean and rinse cls.The pt reported a daily wear schedule with monthly replacement.No further information was provided.On (b)(6) 2019, a call was received from the pt stating that the eye was still swollen, and the pt has not sought any medical attention.The pt reported wearing an old pair of cls previously reported.The pt¿s eyes are currently red and swollen.No further information was provided.On (b)(6) 2020, the pt posted a complaint on an on-line website: the pt reported an allergy to the cls.The pt visited an ophthalmologist who advised the allergy was so severe that the pt is at risk of losing vision.The pt alleges 60% vision in the os.The pt is planning an appointment with a specialist for (b)(6) 2020.The pt noted feeling like ¿it is getting worse.¿ on (b)(6) 2020, additional information was received from the pt: the pt did not have the treating eye care provider (ecp) contact information.The pt reported the ecp did not provide a diagnosis but referred the pt to a specialist.No treatment was prescribed.The pt has a specialist visit scheduled for (b)(6) 2020.No further information was provided.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified with the treating ecp.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 b00pdb9 was produced under normal conditions.Three opened contact lens cases were received containing three contact lenses for lot # b00pdb9.The parameters of the three open lenses were measured, and a visual inspection was performed.No visual attributes were observed for open lens # 1; open lens # 2 revealed a hole; open lens # 3 revealed excess lens material.One lens was observed to be out of specification for power but measured within specifications for base curve, center thickness, and diameter.The remaining two lenses met company standards for power, base curve, center thickness, and diameter.This product was returned opened and it is not known what external influences may have contributed to this out of specification measurement.If any further relevant information is received, a supplemental report will be filed.
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