Catalog Number 8065990601 |
Device Problem
Unstable (1667)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 06/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported unstable laser energy before surgery.After multiple energy tests, treatment was performed on two patients who were noted to have "excessive correction" post treatment.Additional information requested.There are two related reports for this patient.This report addresses the patient one, right eye, and another manufacturer report will be filed for the fellow eye.
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Manufacturer Narrative
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Based on information received prior to the submission of supplemental report (smdr 1), this event does not meet criteria for reporting as a serious injury.(b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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Additional information received states the patient's symptoms have resolved.
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Search Alerts/Recalls
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