Catalog Number 8065990739 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/28/2019 |
Event Type
Injury
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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 due to this device was out of production prior to the (b)(4) 2014 udi regulation date.Device history record (dhr) for the device reviewed.The associated device was released based on company¿s acceptance criteria.The manufacturer internal reference number is: (b)(4).
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Event Description
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An associate reported a patient's wrong eye was treated with lasik.Left eye was planned for treatment only but right was treated.The doctor went on to treat the patient's left eye and then treated the patient's right eye again to reverse treatment.
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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 the day of the treatment.Logfile review showed no abnormalities that could have contributed to reported event.All energy settings were within range and all laser system functions were within specifications at this day.A technical root cause could be excluded, as the system was working within specification.The root cause is user handling.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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