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

Catalog Number 8065750833

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 manager reported that the foot pedal did not respond and the system was not able to perform phacoemulsification.There are no other details at this time.

Manufacturer Narrative

The company service representative examined the system, found the system, and associated footswitch to function as intended.The company service representative determined the issue to be due to nonconforming handpieces, unrelated to the system.The system was then tested and met all product specifications.The system was manufactured on april 29, 2008.Based on qa assessment, the product met specifications at the time of release.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 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, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7481039
• MDR Text Key: 107321735
• Report Number: 2028159-2018-00907
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Other Device ID Number: 380657508334
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI FOOTSWITCH
• Patient Outcome(s): Other