Catalog Number 8065990794 |
Device Problem
Output above Specifications (1432)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.(b)(4).
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Event Description
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A service technician reported high voltage at (b)(4) percent of refractive treatment.Additional information has been requested.
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Manufacturer Narrative
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Additional information provided.The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company acceptance criteria.At the visit on site the field service engineer replaced both 45° deflector and focus lenses to fix this issue.Visual inspection of both the 45° deflectors and focus lenses shows burnings and scratches on all parts.The root cause for the reported problem is the wearing on the 45° deflectors and focus lenses through the usage over long time in the field.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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