ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER
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Model Number 550 |
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 11/30/2022 |
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 healthcare professional reported a patient with torn flap during flap creation, continued on both eyes and patient since the actual treatment bed was not affected the right eye.Bandage lens was placed for patient comfort due to the tear was created an epithelial defect at the hinge.
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Manufacturer Narrative
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A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.Service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.The system found to meet all cosmetic and performance standards.Based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
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