Catalog Number 8065990739 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Visual Impairment (2138)
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Event Date 06/01/2019 |
Event Type
Injury
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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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An optometrist reported a patient presented with seeing shadows and feels weird one day post lasik.The patient was noted to have been treated with distance vision but should have been treated with mono vision.Additional information requested.
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Manufacturer Narrative
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A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to treatment date.Logfile review shows all laser system functions were within specifications for the respective treatment.A root cause of the technical side could be excluded.No technical root cause was identified as the system was operating within specification.The root cause could be user error.The manufacturer internal reference number is:
(b)(4).
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Search Alerts/Recalls
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