Catalog Number 8065990631 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Chemical Exposure (2570)
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Event Date 03/03/2020 |
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.(b)(4).
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Event Description
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A doctor reported refractive result of a patient's second eye was unsatisfying.Following completion of the treatment for the first eye, sterile cleaning solution apparently dripped in the direction of the laser optics when rinsing with the irrigation cannula.There are multiple related reports for this facility.This report addresses the patient (b)(6) left eye and other manufacturer reports will be filed.
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Manufacturer Narrative
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Device history records (dhr) for the device was reviewed.The associated device was released based on company¿s acceptance criteria.During an onsite visit, a field service engineer (fse) found traces of sterile intraocular irrigating solution visible on the eye tracker mirror.Therefore, eye tracker mirror was exchanged.Root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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