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

Model Number 550

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Visual Impairment (2138)

Event Date 01/07/2016

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.Based on manufacturing review, the product met specifications at the time of release.(b)(4).

Event Description

A surgeon reported a patient with low vision acuity following corneal flap creation.Upon additional follow up it was reported the flap was irregular upon optical coherent tomography examination.The surgeon indicates the irregular flap led to unplanned astigmatism.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

Company representatives have visited the site and have been unable to identify an issue with the system.The technical support team and trainers continue to work with the customer and the field representatives to identify and/or eliminate contributing factors to these issues.A review of the manufacturing records did not reveal any related nonconformity during manufacturing for this system.Based on quality 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 ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175686660
• MDR Report Key: 5637491
• MDR Text Key: 44642617
• Report Number: 3008772169-2016-00286
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K101626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• 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: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2013
• 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
• Patient Age: 33 YR