Catalog Number 8065990739 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Syncope (1610)
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Event Date 07/03/2019 |
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 (b)(4) 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 the patient was treated with plus cylinder instead of minus cylinder in the right eye during lasik.The patient fainted at intralase during procedure.The patient will likely undergo an enhancement.Additional information requested.
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Manufacturer Narrative
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Logfile review for the date of treatment shows no abnormalities that could have contributed to reported event.As a review of the logfile shows no treatments were performed with a refraction that similar to the patients pre-refraction.No technical root cause was identified as the product was found to be within specifications.The root cause could not be identified conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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