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); Device Displays Incorrect Message (2591)

Patient Problem Corneal Ulcer (1796)

Event Date 11/12/2020

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.(b)(4).

Event Description

A surgeon reported during the sculpt phase of a cataract extraction procedure the patient experienced a corneal burn.System messages were noted during priming of the handpiece.The handpiece had too much ultrasound in respect to its settings and the tip got hot.There was a wound gap that required sutures for closure.The patient does have corneal opacity and astigmatism.Additional information has been requested and received.This is one of three reports from this facility for the reported event above.

Manufacturer Narrative

The phacoemulsification (phaco) handpiece was not returned for evaluation.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported events could not be confirmed.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, (b)(6) 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.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: 10955163
• MDR Text Key: 219912713
• Report Number: 2028159-2020-01059
• 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: 04/05/2021

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: 11/12/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION ACTIVE FMS PACK; CENTURION ACTIVE SENTRY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR