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

Model Number 550

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2018

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

Event Description

A customer reported gantry movement, it was brief and only occurred once.Additional information received; this event occurred during a treatment but without patient harm.

Manufacturer Narrative

Additional information provided.The company representative was present to observe surgical cases.There were no issues with gantry movements.The company representative then examined the system, but was unable to duplicate the gantry movement when moving the gantry all around.The joystick was replaced as a preventive measure (pm).The system was then tested and met all product specifications.The company service representative observed four (4) surgery cases, with no problems noted.The joystick was received and a visual assessment of the returned sample showed no damage.The sample was installed on a calibrated laser system and tested with no problems found.The sample joystick was found to have full range of motion and operation.No unintended movement was observed.The joystick sample 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
• MDR Report Key: 7833731
• MDR Text Key: 118891705
• Report Number: 2028159-2018-01845
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• PMA/PMN Number: K163551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other