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

Model Number 550

Device Problem Device Displays Incorrect Message (2591)

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

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.Based on assessment, the product met specifications at the time of release.(b)(4).

Event Description

A doctor reported an incomplete corneal cut during laser assisted flap creation.Upon follow up, no error messaged appeared on the screen.Surgeries were completed manually.There are two related reports for this facility.This report addresses an unknown amount of patients and another manufacturer report will be filed for a patients who resulted with some astigmatism.

Manufacturer Narrative

The company service representative examined the system and could not replicate any system nonconformity that may have attributed to the reported event.However, as preventative measures, the surgical focusing module (sfm) internal optics were realigned and the oscillator was calibrated.Additionally, the pockels cell and the 7.5mm aperture were replaced the.The system was then tested and met all product specifications.The root cause 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 LENSX, INC.; 33 journey; suite #175; aliso viejo CA 92658
• MDR Report Key: 8469643
• MDR Text Key: 140632259
• Report Number: 2028159-2019-00573
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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?: Yes
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1