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

Model Number 550

Device Problems Loose or Intermittent Connection (1371); Product Quality Problem (1506); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2015

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.Additional information has been requested.(b)(4).

Event Description

An ophthalmic surgeon reported not expected results on patient's right eye during a laser assisted cataract surgery.Patient interface (pi) was poorly secured into the laser support which resulted in insufficient quality of the rhexis with tags, "rupture" of its integrity, incomplete fragmentation, and the incisions were not functional.It was noted that the base of the pi was loose.Additional information has been requested.This is one of three reports being filed for the same facility.This report is for the second patient.

Manufacturer Narrative

Evaluation summary: a company representative noted that the bayonet retaining ring of the system¿s objective was not completely secured to the system and would not allow the patient interface (pi) to sit in its intended location on the objective.The company representative correctly secured the ring into its position to address the reported events.No additional issues were experienced after the correction.The reported events were a direct result of the patient interface (pi) not sitting correctly on the system during the procedure.As the bayonet ring would only be adjusted by a company representative, it can be concluded that during service of the system, the ring was inadvertently left unsecured.Both they system and patient interface met specifications at the time of release.The root cause of the event can be attributed to a company representative service error.

• 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: 5162689
• MDR Text Key: 29013093
• Report Number: 3008772169-2015-00756
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Other Device ID Number: 00380659981623
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2015
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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: 66 YR