Catalog Number 8065990713 |
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 02/09/2017 |
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.(b)(4).
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Event Description
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An ophthalmologist reported a planning error in case with axis deviations greater than 15 degrees between topography and cylinder measured.There are multiple related reports for this facility.This report addresses patient one's right eye and other manufacturer reports will be filed.
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Manufacturer Narrative
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The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company¿s acceptance criteria.The system history shows no abnormalities that could have contributed to this event.The review shows that the laser was successfully verified prior to and after the date of event/treatment.Clinical investigation on site revealed that cylinder was not included in treatment plan - reason for retreatment.Used wrong protocol for treatment planning.The root cause for the reported planning error was a planning issue in regards to the treated astigmatism value.Apparently, the user was following a wrong protocol and therefore the cylinder was not treated.Thus, the planned treatments lead to an undercorrection of the cylinder (cause it wasn't treated) which would require retreatment of some patients.Specific details for all affected patients are currently not available.(b)(4).
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Event Description
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Additional information was received.Patient is satisfied with result.Visual acuity of this patient is reported to be good.
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Search Alerts/Recalls
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