Catalog Number 8065990723 |
Device Problems
Use of Incorrect Control/Treatment Settings (1126); Energy Output To Patient Tissue Incorrect (1209); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 01/14/2015 |
Event Type
Injury
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Event Description
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A nurse reported cases of overcorrection following refractive surgery.The corneal curvature deviated postoperatively of about 0.5 d from the expected corneal curvature.This case is for a patient´s left eye who experienced undercorrection at five months post lasik treatment.Company representative informed that the nomogram was incorrectly applied and the energy was adjusted too high at the fluence test, by the customer.Training was scheduled for surgeons involved additional information has been requested but not received to date.
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Manufacturer Narrative
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A service visit was performed.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.Additional information has been requested but not received to date.(b)(4).
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Manufacturer Narrative
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Evaluation summary: no material was returned for evaluation.A clinical application specialist identified during the training of the personal on (b)(4) 2015 that the energy settings were correct, confirmed by the passed fluence tests.Log file review showed the treatment was completed to 100 %.All laser system functions were within specifications for the respective treatment.The system history showed that the laser was verified successfully prior and after the date of treatment.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 manufacturer acceptance criteria.No technical root cause was identified as the product was found to be within specifications.The root cause cannot be determined conclusively.
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Search Alerts/Recalls
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