Catalog Number 8065990739 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Code Available (3191)
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Event Date 12/14/2018 |
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.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.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 center director reported, a patient was treated with the left eye prescription on the right eye.The patient was informed at the time of surgery and will undergo an enhancement procedure in the future.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.The laser was successfully verified prior to the day of the treatment.The root cause is user error.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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