ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER
|
Back to Search Results |
|
Model Number 550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 07/19/2023 |
Event Type
Injury
|
Event Description
|
A health care professional reported that the system crashed after docking, system reported error six five zero six, after manually removing the vacuum they disconnected the patient interface from the eye and terminated the surgery and experienced corneal epithelial detachment in the central area of the cornea in the patient unknown eye during cataract surgery.
|
|
Manufacturer Narrative
|
H.3., 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).
|
|
Manufacturer Narrative
|
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.The company representative was unable to confirm nor replicate the reported event.The system was tested and found to meet product specifications.The customer reported event cannot be confirmed.Thus, based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|
|
|