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

Catalog Number 8065752914

Device Problem Vibration (1674)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

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 physician reported that during a surgical procedure the phacoemulsification (phaco) suddenly fails from the phaco handpiece.There is still suction but no vibrations.This is one of multiple reports from this facility.Additional information has been requested but not received.

Manufacturer Narrative

Two handpieces were returned for evaluation and found to meet product specifications.The manufacturing device history record (dhr) of both products were reviewed.Based on assessment, the products met specifications at the time of their respective release.The two phaco handpiece received for evaluation.A visual assessment of the returned samples found no visual non-conformities.The handpieces were connected to a resistance test box, where its¿ input and output impedance were found to be within specification.The handpieces tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpieces were connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpieces to meet manufacturer's specifications per manufacturing test procedure (mtp).The returned handpieces were 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: 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: 11140966
• MDR Text Key: 227058510
• Report Number: 2028159-2021-00036
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• 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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1