Catalog Number 8065990601 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Overcorrection (3006)
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Patient Problem
No Code Available (3191)
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Event Date 04/21/2018 |
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.No udi required due to 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 doctor reported incorrect programming of the cylinder axis during a lasik procedure.Residual astigmatism was treated.Upon follow up, patient was very satisfied with the result of the first eye and has already planned a retreatment of the second eye.The treatment rather than being programmed on the axis of 83 had been incorrectly entered with the axis of 173.The result was the astigmatism was increased by about 3 diopters more.Both the surgeon and the patient seem pretty quiet in managing this type of correction of user error.
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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.Contact with the clinical application specialist stated that the treatment was programmed on the axis 83 and has been incorrectly entered to the axis 173.The result was that the astigmatism was increased about 3 diopters more.The clinical application specialist confirmed it was an user error.The root cause for the reported event could be identified as use error in typing the incorrect axis.A product malfunction is excluded.(b)(4).
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Search Alerts/Recalls
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