Catalog Number 8065990739 |
Device Problems
Intermittent Continuity (1121); Improper or Incorrect Procedure or Method (2017); Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.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 due to 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 customer reported that a technician cleaned the lens of the camera and unknowingly threw off the eye tracker as a result.The surgeon performed the procedure and noted the laser kept getting interrupted but was able to complete the procedure.The surgeon asked the technician to verify the tracker and found that it was significantly out of alignment.The patient was noted to have good results and will continued to be monitored.Additional information requested.There are two related reports for this patient.This report addresses the patient's right eye, and another manufacturer report will be filed for the fellow eye.
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Manufacturer Narrative
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During technical onsite visit the field service engineer (fse) inspected eye tracker system and performed tests.The fse confirmed eye tracker and beam alignment was off.The fse realigned main deflector and eye tracker.The system meets specification.The root cause is improper cleaning/decontamination of the device that caused the eye tracker to shift.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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