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 Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

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.(b)(4).

Event Description

A facility representative reported flaps with uncut areas.The side cut was not open 360 degrees.The flaps were very difficult to open due to the uncut areas which were usually in the inferior or superior quadrant near the hinge.There was no impact on patients or their refractive outcomes.

Manufacturer Narrative

The clinical application specialist (cas) provided feedback on the event stating the ¿docking step procedure, flap centration and line references were perfectly understood by the surgeon.There were several setting adjustments which were made to optimize the flap side cut.There was no side cut consistency and there was no relation established between the quality of the cut and the settings/docking.The system was examined and the company representative was unable to confirm or replicate any system nonconformity which may have contributed to the reported event.The system met specification.The 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 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 RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10684818
• MDR Text Key: 213434233
• Report Number: 2028159-2020-00841
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1