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Catalog Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Pain (1994); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/28/2023 |
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 healthcare professional reported that after cataract surgery in the right eye (od), the patient experienced floaters, endophthalmitis (positive for staphylococcus), pain, decrease visual acuity (va), pain, aqueous cells (present) and fibrin (present).The patient received dexamethasone, vancomycin and ceftazidime (od) for the events.The patient current condition was ongoing.The patient was under continuous monitoring.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation for the report of endophthalmitis, floaters, pain, decrease vision, conjunctival inflammation, aqueous cell; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained; therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received and indicated that, the patient's visual acuity were od - 20/40 and os - 20/60.
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Search Alerts/Recalls
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