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

Catalog Number 8065750833

Device Problem Microbial Contamination of Device (2303)

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

Event Description

A news source reported four patients experienced a multi-resistant strain of pseudomonas 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

Corrected information has been provided in h.7.Remedial action is na and not modification/adjustment as previously reported.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 manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.There is no evidence that the design or performance of the equipment caused or contributed to this reported event.¿ 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: 10816633
• MDR Text Key: 215517649
• Report Number: 2028159-2020-00942
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

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?: 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: 02/12/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI PROCEDURE PAK; OZIL TORSIONAL PHACO HANDPIECE; INFINITI PROCEDURE PAK; OZIL TORSIONAL PHACO HANDPIECE
• Patient Outcome(s): Hospitalization; Required Intervention