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); Operating System Becomes Nonfunctional (2996)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/27/2019

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

Event Description

A nurse reported that after the second case of the day and the last pulse was fired, the suction tube was released and the laser screen froze.A usb error message displayed but there was already a usb inserted.The laser was keyed off and restarted to clear the message.The surgeon took the patient to the operating room and once under the microscope noted a posterior capsule tear.All of the cataract was able to be removed but a three piece intraocular lens was inserted instead of the planned single piece lens.The patient is expected to have no residual problems.The surgeon noted that he does not know when the tear occurred and does not know the cause of it.Additional information requested.

Manufacturer Narrative

After review of reported event, there is no evidence indicating that the integrity of the posterior capsule was compromised by the performance of the system.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 cannot be determined conclusively.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: 9105085
• MDR Text Key: 162694374
• Report Number: 2028159-2019-01728
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR