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

Catalog Number 8065752914

Device Problems Overheating of Device (1437); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

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 physician reported that during a cataract extraction the phacoemulsification (phaco) handpiece had no "ozil" and the handle overheated.Procedure details and patient impact were not provided.Additional information has been requested but not received.

Event Description

Additional information has been requested and received indicating the event took place during a cataract extraction procedure.There was no system message displayed.The case was completed using an alternate handpiece with no harm to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

There was no additional information provided.However, the handpiece was returned for evaluation.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The handpiece was received for evaluation.A visual assessment of the returned sample found no visual non-conformities.The handpiece was connected to a calibrated resistance breakout box, where the output and input impedances were found to be within specification.The returned sample was then connected to a calibrated system, where it passed tuning, and a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the hp was measured and failed to meet specifications.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece to fail to meet specifications.Disassembly of the handpiece revealed that the crystal stack was fused together, causing the observed failure mode.The root cause of the reported event can be attributed to the fusing of the crystal stack causing an electrical short circuit between the high and low electrodes.An internal investigation has been opened, to investigate this issue.An internal investigation has been opened, to investigate this issue.Alcon will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11060128
• MDR Text Key: 223809364
• Report Number: 2028159-2020-01140
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: 13K2YA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1