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

Model Number ASKU

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Corneal Edema (1791)

Event Date 03/31/2019

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

Event Description

A physician reported during a multiple surgical procedure when using a balanced phacoemulsification (phaco) tip there was no setting "seven" on the system and the staff was not able to add that setting.The physician tried setting "four" with the balanced tip and it made a funny noise and did not work at all.The tip was changed to another phaco tip and setting "four" was tried again which resulted in no phaco power.The surgeon decided to try setting "one" and increased the vacuum which helped.The setting issue caused an hour delay in the procedure and the patient experienced corneal edema which made the stents harder to insert.Additional information has been requested but not received.

Manufacturer Narrative

No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The root cause 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: 8535888
• MDR Text Key: 142753986
• Report Number: 2028159-2019-00717
• 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
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON GV; MYALUGIN RING; PROVISC; VISCOAT; VISION BLUE
• Patient Age: 95 YR