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Catalog Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Conjunctivitis (1784); Endophthalmitis (1835); Hypopyon (1913); Blurred Vision (2137); Fibrosis (3167); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/21/2023 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported that after postoperative day 14 of a cataract surgery a 62 years female patient experienced endophthalmitis in right eye with symptoms of sharp pain that started acutely then vision worsened, positive for staphylococcus infection.Patient also presented with conjunctival inflammation <1+, aqueous cell 3+, aqueous fibrin was present, hypopyon after clinical examination.Symptoms were treated with steroids, antibiotics and intravitreal tap injection.Patients symptoms was improving.
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Manufacturer Narrative
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Additional information is provided in sections h.6 and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.A sample was not received at the investigation site for evaluation.Based on the information obtained, the root cause of the reported event is inconclusive.Specific product identifiers (serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this serial number cannot be performed as the serial number is unknown.Based on the information obtained, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data 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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