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

Model Number 550

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/17/2019

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 nurse reported the flap bed was incomplete following flap creation.Additional information received reported the flap was not complete in the middle of the flap.The physician felt it was possibly due to a bubble or patient movement.The patient will have photo refractive keratectomy (prk) in the future.The patient is doing well.

Manufacturer Narrative

The company service representative examined the system and was unable to confirm or replicate any system nonconformity.The system was then tested and met all product specifications.The root cause of the reported event can be attributed to patient conditions/non-product related factors.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: 8780733
• MDR Text Key: 150814692
• Report Number: 2028159-2019-01270
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1