Model Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Edema (1791); Loss of Vision (2139)
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Event Date 07/05/2023 |
Event Type
Injury
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Event Description
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A customer reported that after cataract surgery a patient experienced corneal edema and loss of vision.The current outcome of the patient condition was unknown.This report pertains to ophthalmic operating system involved in this reported event.
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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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Manufacturer Narrative
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Additional information provided in sections h.6 and h.10 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.The serial is unknown.Therefore, a service history review cannot be performed.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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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received that patient cannot see nothing with eye and patient underwent surgical intervention for the reported event vision loss and corneal edema.Additional information has been requested and none received till date.
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Search Alerts/Recalls
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