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

Catalog Number 8065751763

Device Problem Inability to Irrigate (1337)

Patient Problems Collapse (2416); Capsular Bag Tear (2639)

Event Date 09/16/2020

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

Event Description

A customer reported that during two separate cataract procedures, multiple system messages displayed and the system lost irrigation during phacoemulsification.The anterior chamber collapsed and posterior capsular tore.The surgeon completed the procedure by doing a vitrectomy and implanted the intraocular lens (iol) intended for both the patients.The surgeon stated both patients would be fine.

Manufacturer Narrative

The company service representative examined the system and confirmed system messages (sm) [unable to achieve irrigation pressure.] and [aspiration, phaco power, and vitrectomy cutting are unavailable.] numerous times in the event log.The company service representative was unable to duplicate the issue.The fluidics module and the fluidics printed circuit board (pcb) were replaced as a precautionary measure.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The reported events of vitrectomy being performed and the patient experiencing an anterior chamber collapse and torn capsule were unable to be confirmed.The root cause 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: 10606365
• MDR Text Key: 209181054
• Report Number: 2028159-2020-00782
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention