Catalog Number 8065751763 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Conjunctivitis (1784); Corneal Edema (1791); Hyperemia (1904); Inflammation (1932); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/20/2021 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that post operatively patient experienced significant distortion of the cornea and prolonged inflammation of the sclera near the wound.Additional information has been requested but none received to date.
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Manufacturer Narrative
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The sample has been received and in-house evaluation is in progress.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received indicating the patient was experienced strong inflammation occurred from the sclera to the conjunctiva near the scleral wound, mild to severe eye pain, hyperemia and was given with subconjunctival injection of steroids.The symptoms got resolved.
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Manufacturer Narrative
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The company representative (did not) confirm nor replicate the reported event.However, the usb data file with the event logs was returned to manufacturing to review for this investigation.The system was tested and found to meet product specifications.A non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.A usb data file was received for evaluation.The contents of the file included the event log for the system.The event log corresponding to the case referenced in the reported event showed no system messages displayed during the surgery.The event log did not indicate any potential contributing factors to the reported event.The system was found to meet specifications.Therefore, 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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