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 03/13/2020

Event Type  Injury  

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.Alcon lensx (site #(b)(4)) is no longer operational.Lensx manufactured products are maintained and investigated by the alcon research, ltd.Irvine technology center site (#(b)(4)).The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported while docking looked great, the capsulorhexis was only half completed in the left eye during laser assisted cataract surgery.The wound shifted into the conjunctiva and the arcuates were shifted over to the side.The surgery was completed manually and no change to surgical plan.The patient will be seen in follow up at a later date.Additional information received states the patient is happy with the result.

Manufacturer Narrative

Additional information provided in h.3, h.6, and h.10.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.Information received from the clinical application specialists (cas) states, ¿on the pictures, you can see that the eye (though blurry) was tilted a bit.It was fairly level during the circle scan.By the time the line scan was captured, there was a fair amount of tilt.As can be seen on the line scan, the left vertical magenta line indicating the capsulorhexis is barely on the anterior surface of the lens, and the right vertical magenta line is deep into the lens.Because the magenta lines in both the circle scan and line scan, represent the same feature (capsulorhexis).¿ the root cause of the reported event can be attributed to patient eye tilt between the circle scan and line scan, which is a non-product related factor.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: 9928748
• MDR Text Key: 188325672
• Report Number: 2028159-2020-00325
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR