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

Catalog Number 8065750833

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inflammation (1932)

Event Date 01/23/2019

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 acute inflammatory syndrome on several patients after a surgical procedure.The syndromes did not have germs or bacteria and appeared the next day.The staff questions the cleaning and sterilization of the products.Additional information has been requested but not received.This is one five reports from this facility.

Manufacturer Narrative

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

Manufacturer Narrative

The company service representative examined the system and was not able to confirm the reported event.The system was then tested and met all product specifications.The company representative made plans to review sterility and directions for use (dfu) with the customer.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.Five (5) opened irrigation/aspiration (i/a) handpieces were returned for evaluation.It is not know which handpiece goes with which complaint.One photo was provided and reviewed.The photo shows the five i/a handpieces.A visual inspection of the five handpieces were performed and all were deemed nonconforming based on the use of the handpieces for numerous years of service.The front adapter edges are worn from placement of i/a tips on and off the handpieces.One handpiece did have a very large gouge on the front adapter surface.There are no areas of material buildup in the female luer, male luer, or front adapter inside diameters.There are no visual brazing corrosion issues.All reusable handpieces are 100% visually inspected, functionally tested, and cleaned during the manufacturing process.These i/a handpieces have seen their useful service life.A review of the device history record traceable to three possible reported lot numbers for the samples returned indicates that the product was processed and released according to the product¿s acceptance criteria.There is no evidence that the design or manufacturing of the system or i/a handpiece contributed to the reported event.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The i/a handpieces all were deemed nonconforming based on the use of the handpieces for numerous years of service.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: 8392112
• MDR Text Key: 137880941
• Report Number: 2028159-2019-00355
• 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,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ULTRAFLOW I/A THREADED HANDPIECE
• Patient Outcome(s): Other