Catalog Number 8065990941 |
Device Problems
Bent (1059); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Code Available (3191)
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Event Date 07/17/2017 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A doctor reported he was unable to complete correct placement of the presbyopic corneal inlay of the left eye due to tight tissue opening of the cornea.Upon follow up with company clinical application specialist (cas), it was reported the surgeon indicated the opening was tight and the inlay was inserted.The surgeon was unable to place the inlay correctly in the pocket and opted to remove it.The surgeon did perform a hyperopic lasik treatment as preparation of the inlay insertion at a later date.Cas also indicated the tool used for inlay insertion had somehow become bent making it even more difficult to complete the insertion process.
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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 acceptance criteria.The system history shows that the laser was verified successfully prior to and after the date of treatment.The root cause could not be identified conclusively.(b)(4).
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Search Alerts/Recalls
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