Age/date of birth: unknown/ not provided.Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2018.If explanted; give date: not applicable; there is not indication lens has been explanted.Brand name: unknown/not provided.Serial#: unknown/not provided.Catalog/ model#: catalog and model # unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi #: udi # is unknown as product serial number was not provided.Device manufacture date: unknown, as the serial number of the device was not provided.The device was not returned for analysis (the lens remains implanted).The serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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A female patient reported that she had cataract surgery performed on both eyes (ou) on (b)(6) 2018.Reportedly, days later, the patient complained to a group of friends that she had infections in both eyes because of the surgery.The patient reported that she had an epi-retinal flap in both eyes, and that the retina doctor told her that some people with that experience swelling around the flaps after eye surgery.The patient also confirmed that her intraocular lenses (iols) were from johnson and johnson surgical vision.No additional information was provided.This report pertains to the patient'' left eye (os).A separate mdr report will be submitted for the patient's right eye (od).
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