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

Catalog Number 8065751761

Device Problems Complete Blockage (1094); Leak/Splash (1354); Output Problem (3005)

Patient Problems Discharge (2225); Injury (2348); Eye Burn (2523)

Event Date 02/27/2019

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 customer reported that during a cataract procedure, a patient experienced a thermal injury, in the right eye.The system alarmed an occlusion during the sculpting phase.The phaco handpiece was removed and flushed and retested, which resolved the issue as no occlusion bell was detected.Then sculpting was resumed and immediately became clogged again.The handpiece was immediately removed, but the corneal wound burn had already occurred.A new handpiece was setup and was used to complete the rest of the case without complications.Anterior shallowing and wound leakage was noted.Suture and tissue glue were required.The patient is noted to have postoperative astigmatism, however, the amount has not yet been quantified by topography.The patient prognosis is reported as good with protracted healing.

Manufacturer Narrative

The company service representative examined the system and no problems were found.The phaco handpiece was tuned and tested from 0-100% power in both longitudinal and torsional settings with no problems noted.The system was then tested and met all product specifications.There were no technical services requested or performed related to the reported event.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.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, 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: 8453686
• MDR Text Key: 139955931
• Report Number: 2028159-2019-00515
• Device Sequence Number: 0
• Product Code: HQC
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention