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

Model Number 550

Device Problems Decrease in Suction (1146); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 11/07/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.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 manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported a broken capsule post laser assisted cataract procedure.The device energy was low and a patient interface suction error occurred.The device negative pressure was decreased which caused the water to enter the patient interface tubing.The procedure was incomplete.The "chopping" was lens fragmentation, reportedly not done and the intraocular lens was placed in the ciliary sulcus.Additional information has been requested.

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.The system history shows that the laser was verified successfully prior the date of treatment.The technical investigation shows that the device meets the specifications.The root cause cannot be determined conclusively.

Event Description

The company representative confirmed that around 12 o'clock there were tears of both anterior capsule and posterior capsule.

Manufacturer Narrative

A supplemental medical device report (smdr) #2 is being filed to correct the date received by mfr on the prior filed initial report.Incorrect date of 11/09/2015 being corrected to 11/07/2015.(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: 5371513
• MDR Text Key: 36208052
• Report Number: 3008772169-2016-00051
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• 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: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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; Required Intervention
• Patient Age: 47 YR