MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number 550

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2020

Event Type  malfunction  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported a side cut tag during a refractive procedure on a patient's right eye.Flap creation was performed by laser and everything looked fine.The surgeon moved over to the excimer laser and started dissecting.The surgeon noticed that the hinge seemed wider than normal.The side cut was made but there was a tag.The surgeon was able to pop thru the tag with a lifter and reflect the flap.The patient interface was checked.It was noticed that a slight, light etching was inside of the created side cut etching from eleven o'clock to ten o'clock.Treatment was completed and flap was laid back down with no other issues.There are two related reports for this patient.This report addresses the patient's right eye and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

The surgeon noted everything looked fine.After the surgeon moved over to the excimer laser and started dissecting ,the surgeon reported that the hinge seemed wider than normal.The surgeon looked at it closer when dissecting and noticed the side cut was made there but there was a tag.The surgeon was able to pop through the tag with a lifter and reflect the flap.The company clinical applications specialist (cas) then went over to the right patient interface (pi) and checked the glass and noticed a slight light etching inside of the created side cut etching from about 11 o¿clock to 10 o¿clock.The flap was reflected, the treatment was completed and flap laid back down with no other issues.There was no patient harm.The company service representative examined the system and found that the oscillator was unstable which may have contributed to the reported event.The company service representative temperature tuned the oscillator, adjusted the dump timing to improve the figure of merit (fom) and performed various adjustments to the xy galvo gains, application force, spot size and energy calibration.The system was then tested and met all product specifications.The system was examined again.The company was able to confirm and replicate a nonconformity in the surgical focusing module (sfm) which had contributed to the reported event of flap side tags.The sfm was replaced.The system was then tested and met all product specifications.The company service representative monitored the site following the sfm replacement and there have been no additional reports of flap side cuts.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a nonconforming sfm.The manufacturer internal reference number is: (b)(4).

• Brand Name: LENSX LASER SYSTEM
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10791186
• MDR Text Key: 216838581
• Report Number: 2028159-2020-00924
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• 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: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENSX PATIENT INTERFACE-10/BOX
• Patient Age: 26 YR