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

Catalog Number 8065751763

Device Problems Display or Visual Feedback Problem (1184); Connection Problem (2900); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Swelling (2091); Capsular Bag Tear (2639)

Event Date 04/03/2019

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.(b)(4).

Event Description

A nurse reported during a cataract extraction procedure with intraocular lens implant procedure in the left eye a system message was displayed and the foot switch did not work.The staff attempted several tries of reconnecting the cable and turning the machine off and on with no resolution to the issue.The female patient experienced a posterior capsule tear.The eye swelled making it impossible to insert the intraocular lens due to the 2 hour delay in the procedure.Additional information has been requested.

Manufacturer Narrative

The footswitch serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause of the reported event 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: 8559925
• MDR Text Key: 143377624
• Report Number: 2028159-2019-00771
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• 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?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION FOOTSWITCH; CENTURION FOOTSWITCH
• Patient Outcome(s): Other
• Patient Age: 72 YR