Catalog Number 8065990794 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Blurred Vision (2137)
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Event Date 12/04/2020 |
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 physician reported a patient with incorrect axis treatment in the right eye post lasik procedure.Patient noted blurred vision.Temporary glasses were prescribed.An enhancement will be performed in the future.Additional information has been requested.
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Event Description
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Additional information received from the physician stated, patient¿s symptoms were resolved following an enhancement procedure and device did not cause the event.
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Manufacturer Narrative
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Additional information provided in b.5.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury incident.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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