Catalog Number 8065753008 |
Device Problem
Component Missing (2306)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/01/2020 |
Event Type
malfunction
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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 customer reported no ozil with the ophthalmic system.Procedure details and patient impact where not reported.
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Manufacturer Narrative
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The company service representative examined the system and was not able to confirm or replicate the reported event.The system software was upgraded as a preventative measure (pm).The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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