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

Model Number 550

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 05/17/2017

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.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.(b)(4).

Event Description

A nurse reported during a laser assisted cataract procedure a surgeon indicated the whole lens dislocated posteriorly.Reporter stated, laser portion of the procedure was completed with no complications, and the event occurred at the start of phacoemulsification.The patient is scheduled for posterior segment lens retrieval and iol implant.Upon follow up, reporter indicated the surgeon was halfway through doing a central nucleus groove when the capsule ruptured.The surgeon mentioned that the same patient had a posterior capsule rupture in the fellow eye previously with a different surgeon and on a standard conventional non-laser assisted case.Surgeon mentioned the patient may have some congenital issue with her posterior capsule.

Manufacturer Narrative

No technical services were requested or performed on the system due to the reported event.Optical coherence tomography (oct) scans or system settings were reviewed, and no abnormalities were found.In addition, there were no reported system messages or system issues that would clearly indicate that the laser system caused or contributed to the event.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: 6640220
• MDR Text Key: 77540519
• Report Number: 3008772169-2017-00313
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2014
• 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: 75 YR