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 Date 03/21/2018

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.(b)(4).

Event Description

A surgeon reported an error during the laser portion of laser assisted cataract surgery.The system was shut down and rebooted.After clearing the error the site was able to proceed with the laser treatment without other issues.Following removal of the cataract in the operating room the surgeon noticed a hole on the inferior side of the posterior bag.A three piece intraocular lens was placed and the primary incision was sutured.Additional information has been requested.

Manufacturer Narrative

Based on assessment, the product met specifications at the time of release.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
• Manufacturer (Section G): ALCON LENSX, INC.; 33 journey; suite #175; aliso viejo CA 92658
• Manufacturer Contact: bryan blake ; 33 journey; suite #175; aliso viejo, CA 92658 ; 8176152230
• MDR Report Key: 7434001
• MDR Text Key: 105595742
• Report Number: 3008772169-2018-00087
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• 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
• Device Lot Number: ASKU
• Other Device ID Number: 00380659981623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR