Catalog Number 8065990739 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/01/2020 |
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.No udi required as this device was out of production prior to the september 24, 2014 udi regulation date.(b)(4).
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Event Description
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A health professional reported a secondary energy message during refractive treatment.The procedure was completed successfully.Additional information received; the patient did not experience any issues as a result of this event.There are two related reports for this event.This represents patient (b)(6) and an additional report will be filed.
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Manufacturer Narrative
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A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.Logfile review shows multiple error messages can be found in logfiles.The messages might occur if a gas change is needed and during the evacuation of the lines if the pressure does not fall below a set limit.A gas change was performed.During technical onsite visit the field service engineer (fse) replaced a sensor, beam splitter and performed system verification as per sir (service installation record).Root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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