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

Catalog Number 8065752914

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxicity (2333)

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

Event Description

A surgeon reported several toxic anterior segment syndrome cases over the past several months.Additional information has been requested but not received.This is one of two reports from this facility.

Manufacturer Narrative

Additional information has been provided in h.6.And h.10.The reported handpiece was not received for evaluation.There was no further information obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The reported handpiece was not received for evaluation.There was no further information obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The root cause 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: 9884136
• MDR Text Key: 186519328
• Report Number: 2028159-2020-00278
• 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,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 04/30/2020; 04/30/2020
• Supplement Dates FDA Received: 05/06/2020; 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI ULTRASOUND HANDPIECE
• Patient Outcome(s): Other