MAUDE Adverse Event Report: ALCON LENSX, INC. LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number 550

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

A surgeon reported that after flap creation while attempting to lift the flap, the flap was different than ones previous created by the instrument.Tomography printouts showed that the device cut a flap which in the x axis started from around 210 microns and finished at around 50 microns.Upon follow up, this patient was the first one operated on after installation of the system.Field service engineer completed all the appropriate check lists and parameters during the installation.The doctor copied and used parameters from his old device.The surgeon lifted the flap because he did not realize there was a malfunction with the system.The patient resulted with astigmatism but the amount is unknown at this time.The site was visited and a tilted objective lens was found.There are two related reports for this patient.This report addresses the patient's left eye and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

The clinical application specialist (cas) provided feedback from the event.The company installed the system before the surgeries were completed and the system met specs before leaving.The case was completed, right after the installation.It was mentioned that the settings were copied over from the old device.The surgeon did not notice an issue until the optical coherence tomography was used to observe the patient.However, the surgery proceeded under the direction of the surgeon.Upon learning about this issue from the customer, the cas visited the site and discussed the potential issues over the phone with the company representative.Upon the company representative finishing system installation, the system was found to meet specifications.The system settings and parameters were carried over from the sites prior system.There was no additional information provided.Therefore, the root cause of the reported event cannot be determined conclusively.Based on assessment, the product met specifications at the time of release.The manufacturer internal reference number is: (b)(4).

• Brand Name: LENSX LASER SYSTEM
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): ALCON LENSX, INC.; 33 journey; suite #175; aliso viejo CA 92658
• MDR Report Key: 8341043
• MDR Text Key: 136229095
• Report Number: 2028159-2019-00234
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• PMA/PMN Number: K163551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other