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

Catalog Number 8065751763

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 02/03/2021

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 two patients experienced capsule rupture during surgery.An anterior vitrectomy was required.

Manufacturer Narrative

The company service representative examined the system and found the system to function as intended.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported events cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11340935
• MDR Text Key: 232319607
• Report Number: 2028159-2021-00167
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• 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: 07/08/2021

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: 8065751763
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other