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

Catalog Number 8065750833

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Vision (2139); Drug Resistant Bacterial Infection (4553); Drug Resistant Bacterial Infection (4553)

Event Date 10/13/2020

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 news source reported four patients experienced a multi-resistant strain of pseudomonas with vision loss in one eye following cataract extraction procedures at a facility.The patients were immediately admitted to other facilities for medical and pharmaceutical treatment.A site inspection was performed of the operating room where the surgical procedures took place.After review of the inspection results, a decree for suspension of the operating room was issued.Additional information has been requested and received indicating all of these patients underwent diagnostic-therapeutic vitrectomy procedure and received antibiotic treatment.Further information is not expected at this time.This is one of two reports for this facility.

Manufacturer Narrative

The infiniti is a closed system.It is operated with a sterile single use consumable cassette, which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (phaco handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).The phaco handpiece is a reusable device that must be reprocessed per the product dfu.There is no evidence that the design or performance of the infiniti system or cassette pak caused or contributed to this reported event of endophthalmitis.A review of the service records (sr) showed that no sr was opened for this event.With no additional, related information provided, the customer reported event could not be confirmed.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.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: 10816176
• MDR Text Key: 241258911
• Report Number: 2028159-2020-00940
• 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: 02/12/2021

1 Device was Involved in the Event

2 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 10/18/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention