MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number 550

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 08/03/2020

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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported suction was lost midway through flap bed creation.Partial flap resulted.Procedure was not completed and photo refractive keratectomy (prk) is planned for the future.The doctor feels the laser suction is too weak for flaps.Clinical applications specialist observed that the surgeon started with the left eye.The eye was docked and suction was turned on.There were bubbles around the limbus at ten o'clock and two o'clock.Suction was turned off.The surgeon dried the conjunctiva with the corner of a tissue and re-docked.Contact with the eye was good all around.Procedure was started.White bubbles appeared a third to half of the way though treatment where contact was not good during the first attempt.Suction was broken.No patient movement was noticed.Treatment was aborted.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.A service request (sr) was opened for standard preventative maintenance (pm).A company representative assessed the system and was unable to confirm or replicate any system nonconformities which may have contributed to the reported event.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event could not 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 RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10447355
• MDR Text Key: 205109061
• Report Number: 2028159-2020-00664
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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?: Yes
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR