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

Model Number 550

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 04/08/2016

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 difficulty lifting a patient's left eye flap during laser assisted flap creation.A diamond knife was used to dissect sidecuts into segments.There are two related reports for this patient.This report addresses the patient's left eye and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

The customer reported incomplete flap incisions.Manual completions of the incisions were performed using a diamond blade knife with no reports of further patient impact.The system was upgraded to a new software which includes a mitigation to a potential system-related contributing factor.Following the upgrade, the customer performed two additional flap treatments that resulted in incomplete bed treatments.However, the videos show that the surgeon did not fully verify that the side cuts had been completed before attempting to lift the flaps and resorted to manual cuts with a blade.Thus, it could not be determined if the side cut incisions were actually completed or not.Even if the side cuts were not completed, the cause of the incomplete bed treatments would introduce another possible contributing factor to consider.The technical support team and clinical applications specialists trainers are continuing to work with the customer and the field representatives to identify and/or eliminate contributing factors to these issues.With the information obtained at this time, however, the root cause of the incomplete side cuts could not be determined conclusively.A review of the manufacturing records did not reveal any related nonconformity during manufacturing for this system.Based on assessment, the product met specifications at the time of release.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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5628585
• MDR Text Key: 44332736
• Report Number: 3008772169-2016-00274
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• PMA/PMN Number: K101626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2016-010
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR