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

Catalog Number 8065750833

Device Problems Overheating of Device (1437); Device Inoperable (1663)

Patient Problem Eye Burn (2523)

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 the handpiece did not work and heated the patient experienced a corneal burn.Additional information has been requested.

Manufacturer Narrative

The company service representative examined the system and the system worked as intended.The system was then tested and met all product specifications.Additional information was requested with none received to date.Corneal thermal injuries are typically related to excessive heat generated by the phaco tip due to insufficient aspiration flow, extended energy application, or combination of both.The system is designed to cool the phaco tip during use as aspirated fluid flows through the tip lumen.Overheating of the phaco tip, however, may occur due to extended application of ultrasonic energy or compromised aspiration flow through the phaco tip.Reduced fluid flow through the phaco tip may be caused by phaco tip re-use, tip clogging by nuclear material, kinked tubing, inadequate flow and vacuum settings, or obstruction by ophthalmic viscoelastic device (ovd).When the phaco tip is occluded, infusion will cease, reducing the cooling effect of the tip.Occlusion tones (intermittent beeping tones during occlusion) alert the user, indicating that the vacuum is near or at its preset limit, and aspiration flow is reduced or stopped.The surgeon must recognize the occlusion tones and manually stop the ultrasound mode in order to prevent a rapid temperature increase.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.The phaco handpiece 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: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7253228
• MDR Text Key: 99530644
• Report Number: 2028159-2018-00262
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

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: 8065750833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other