MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751761

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

A sample has been received by manufacturing that has not yet been evaluated.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 customer reported that during a surgery handpiece got hot.Procedure details and patient impact have not been provided.Additional information has been requested, additional information received indicating during a cataract extraction a handpiece continued to be hot.There was no system message.Handpiece was changed and surgery was completed.There was no medical intervention required.There was no patient harm.

Manufacturer Narrative

This complaint was opened to address a reported event of temperature high.The handpiece was confirmed to have exhibited a failure mode related to a nonconforming crystal stack.This event type is consistent with a known, previously investigated issue.It is important to note that the elevated shell temperature of the handpiece is not instantaneous as a result of this event; it gradually increases with use, and can take up to approximately 5 minutes to heat up.During product use training, the surgeon is advised to discontinue use of the handpieces if there are any indications of the handpiece reaching its end of life.Quality assurance will continue to monitor for evidence of adverse trending of reported events and take further action, as appropriate.At a minimum, this will include completing reviews of complaint event code levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 12147450
• MDR Text Key: 260987944
• Report Number: 2028159-2021-00723
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517619
• UDI-Public: 00380657517619
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Device Lot Number: 13MK6K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1