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

Model Number 8065998162

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

Event Type  malfunction  

Event Description

Femto assisted cataract surgery.When the surgeon stepped on the laser pedal to apply the treatment, there was no laser emission.The machine indicated that it was applying the treatment and it produced a treatment record but there were no visible signs of the laser treatment on the patient's eye.The alcon lensx representative was present in the room.He recommended that we re-start the machine.We waited for the machine to do a quick warm up and opened a new patient interface (pi) and contact lens.After restarting the machine and applying the new pi, the laser treatment was successful.However, this caused about 15-minute delay.

• Brand Name: LENSX
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 12391193
• MDR Text Key: 268906978
• Report Number: 12391193
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065998162
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA