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

Model Number 550

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There are multiple non-system related contributing factors that could contribute to the reported event such as anatomical abnormalities, patient movement, or surgical technique.A company representative visited the site to evaluate the system due to the reported event.Per the company representative, flap calibration was performed on the system to address the reported event.The company representative then tested and verified the system to meet specifications prior to departure.Based on the results of this investigation, the reported event was confirmed.Based on quality assurance assessment, the product met specifications at the time of release.Based on the information obtained, the root cause of the reported event can be attributed to system¿s flap calibration was off.However, at the time of the investigation, it¿s unknown how the calibration was off calibrated.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that lifting the flap was poor and the side cut was not good.No additional information available.

• 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: 6847977
• MDR Text Key: 85582937
• Report Number: 3008772169-2017-00497
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K101626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• 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: 08/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2014
• 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