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

Catalog Number 8065750833

Device Problems No Display/Image (1183); Decrease in Pressure (1490)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/03/2019

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

Event Description

A customer reported it was impossible to increase the intraocular pressure (iop) and the patient experienced a drop in pressure in the anterior chamber.No system message was displayed.The system was re-booted and consumable products were changed without resolution to the issue.The case was stopped and the patient was transferred to another facility for completion.Additional information has been requested and received.

Manufacturer Narrative

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

Event Description

Additional information received indicated there was no change in pressure despite pressure on the footswitch.

Manufacturer Narrative

The company service representative examined the system and no problems were found.However, as a preventive measure the fluidics, footswitch, and cabling were all replaced at the request of the surgeon.The system was then tested and met all product specifications.The surgeon has requested to continue tutelage with a company representative to ensure parameters are adequate.The operator¿s manual includes the warning: empirical numbers for bottle heights are not a replacement for competent surgical technique.The surgeon should visually and physically monitor intraocular pressure.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 event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI 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: 8280802
• MDR Text Key: 134181874
• Report Number: 2028159-2019-00147
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI ENHANCED FOOTSWITCH
• Patient Outcome(s): Required Intervention