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

Model Number 550

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A surgeon reported that following the laser assisted portion of cataract surgery, the lens fell through the capsule.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: 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).

Manufacturer Narrative

Evaluation summary: the system history showed that the laser was successfully verified prior to, and after the date of treatment.The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on the manufacturer's acceptance criteria.The technical investigation shows that the system was examined and the reported event was not replicated.The system was tested and found to meet specifications.The customer did not report any system messages or an unexpected deviation to the laser treatment.Thus, at this time, there is no evidence contained within the reported information that indicates that the design or performance of the system contributed to the event.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (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: 4857832
• MDR Text Key: 5847502
• Report Number: 3008772169-2015-00596
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2013
• 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