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

Model Number 550

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2020

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 surgeon reported during a laser assisted cataract operation, the capsulotomy was unable to be seen.The laser apparently lasered the capsulotomy into the lens instead of into the front lens capsule.The surgeon reported that it must have been a deep anterior chamber with a thick lens because he did not see the back surface of the lens in the optical coherence tomography (oct).The surgeon wanted to use a new patient interface but was unable to suppress an error message so the laser was restarted.Capsulorhexis was performed manually.The surgeon decided to finish the operation manually and it went well.No harm to the patient was reported.Upon follow up, the laser has worked perfectly since this procedure.The patient was treated manually and was not impaired.

Manufacturer Narrative

The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received.Surgery management reported that the device still worked as expected on the same day.This problem only occurred in this case.The device worked on the following operating days.The doctor wrote to the clinical applications specialist (cas) that he had set the points correctly and that there had to be a shift afterwards.

Manufacturer Narrative

Additional information provided in h.3., h.6., and h.10.The root cause of the reported event can be attributed to incorrect placement of the capsulotomy control points.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 92658
• MDR Report Key: 9905410
• MDR Text Key: 187546462
• Report Number: 2028159-2020-00303
• 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,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENSX SOFTFIT PI.
• Patient Age: 47 YR