Model Number 550 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/12/2020 |
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 that three patients showed a larger than programmed flap thickness post refractive procedure.New information was received.It is necessary to wait at least three months to see how things resolve and if a touch up is needed.There are multiple related reports for this facility.This report addresses the patient two's right eye and other manufacturer reports will be filed.
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Manufacturer Narrative
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Correction g.4: a supplemental medical device report (smdr) is being filed to correct the g.4 date on the prior filed medical device report.Incorrect date of 11/16/2020 is being corrected to 11/18/2020.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The system was examined, the system, the company representative was unable to confirm or replicate the reported event.The system was tested and found to meet specifications.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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