Model Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypopyon (1913); Inflammation (1932); Vitritis (2181); Fibrosis (3167); Toxic Anterior Segment Syndrome (TASS) (4469)
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Event Date 04/28/2021 |
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.This is the first of four reports for this reported patient event.The manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure.The patient presented post-operative day one with 1+ central corneal folds with no pain, no fixed or dilating pupil and no lid swelling.Upon examination of the patient, the surgeon noted inflammation, 4+ aqueous cell (ac), presence of aqueous fibrin, hypopyon and 3+ vitreous inflammation.The patient was observed for a day and was referred to retina center for further treatment on post operative day two.The patient was treated with vitreous tapered antibiotic injection.Cultures were performed which showed no bacterial growth.The patient's symptoms have resolved.This report represents the first of three patients for this surgeon.
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Manufacturer Narrative
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Corrected information provided.Fda patient event code "3167" was incorrectly selected and has been removed.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information is provided in sections h.6 and h.10.There were no samples returned for evaluation.There was no further information provided by this customer.With no additional, related information provided, the customer reported event was not able to be confirmed.Based on the information obtained, the root cause of the reported events cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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