Catalog Number 8065751763 |
Device Problem
Defective Device (2588)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/11/2023 |
Event Type
Injury
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Event Description
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A physician reported that during a cataract procedure an ophthalmic system displayed a system message (sm).The message was not able to be skipped, procedure was completed successfully by shifting the patient to another facility without any harm to the patient.
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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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The company representative was able to replicate the reported event.The footswitch¿s (domed) up-switch printed circuit board (pcb) was replaced to address the issue.The system was tested and found to meet product specifications.A non-conformance based review of the 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 serial number was performed.No similar complaints were reported for the product serial under investigation.The root cause of the reported event is attributed to the footswitch¿s (domed) up-switch printed circuit board (pcb).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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