Catalog Number 8065998286 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/08/2024 |
Event Type
Injury
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Manufacturer Narrative
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H.6.: 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 healthcare professional reported that the patient had three diopter of residual sphere in the right eye.The patient underwent lasik about ten years back and left with residual refraction.The surgeon did a retreatment procedure with stream light method.There are two related reports for this patient.This report addresses the patient initial sa's right eye and another manufacturer report will be filed for the fellow eye.
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Search Alerts/Recalls
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