Catalog Number ASKU |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Autoimmune Reaction (1733)
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Event Date 04/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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A physician reported a patient experienced an immune response following a cataract extraction procedure with intraocular lens implant.The patient was treated with cortisone.Additional information has been requested but not received.
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Manufacturer Narrative
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Additional information has been provided in a.1., b.3., b.5.And h.6.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received indicating the patient presented to post operative appointment the next day with edema and conjunctival hemorrhage.The anterior chamber was rinsed and topical treatment was required, there was a temporary change in the patient's visual acuity.The patient was given a post operative preventative treatment of steroid and antibiotic for fifteen days.
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Manufacturer Narrative
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Additional information has been provided in h.6.And h.10.In the previous twelve months there were no similar complaints.No customer sample was returned.A review of the batch record and raw materials found no gluten.Root cause cannot be determined based on current available data and no sample received.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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