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

Model Number 550

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem Scarring (2061)

Event Date 10/05/2017

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 flaps that were difficult to lift following lasik flap creation.The flap edges were not adequate and it was difficult to get under the flap.Once dissection was started the surgeon had to use a wekcel to push the outer corneal surface down and pop out the other side of the flap.There was mild scarring around the edges of the flaps and the patient is seeing well.There are two related reports for this patient.This report addresses the patient's right eye, and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

The company representative visited the site and performed preventative maintenance on the system and there were no system issues found that could contribute or be the cause to the reported event.System was tested and verified to meet specifications during the visit.There are many potential clinical factors that could have contributed to the reported event; however, with no additional, related information provided, the customer reported event was not able to be confirmed.Based on assessment, the product met specifications at the time of release.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.(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: nadia bailey ; 33 journey; suite #175; aliso viejo, CA 92658 ; 8176152230
• MDR Report Key: 6991372
• MDR Text Key: 90706951
• Report Number: 3008772169-2017-00529
• 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: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Other Device ID Number: 00380659981623
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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): Other
• Patient Age: 23 YR