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 Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

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.Alcon lensx (site # (b)(4)) is no longer operational.Lensx manufactured products are maintained and investigated by the alcon research, ltd.Irvine technology center (site # (b)(4)).The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported an irregular flap and a wavy stromal bed following corneal flap creation of the left eye.There are two related reports for this patient.This report addresses the patient's left eye, and another manufacturer report was previously filed for the fellow eye.

Manufacturer Narrative

The company service representative examined the system and was unable to confirm or replicate the reported event.Parts were replaced.It was determined by the company service representative that the system was not suitable for flap creation, so the flap mode was deactivated.The system was then tested and met all product specifications for use in laser assisted cataract surgery.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 RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 8184398
• MDR Text Key: 131127914
• Report Number: 2028159-2018-02663
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K163551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• 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