Serial #: serial number is unknown as it was not provided.Udi #: unique identifier is unknown as serial number was not provided.Manufacture date: manufacturer date is unknown as serial number was not provided.Device evaluated by mfr: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Customer reported that one of their patients had a bad reaction after the treatment with the lipiflow.Dr.(b)(6) described the patient as having very red eyes, pain and possible herpetic infection.Dr.(b)(6) prescribed her lotemax.At a follow up visit, patient is still experiencing pain and redness.The patient has a history of shingles.
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