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

Catalog Number 8065750833

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2019

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 surgeon reported the irrigation got extremely less during a procedure and a kink in the tubing was observed.The product was replaced and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

The lot complaint history was reviewed, this is the third complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The customer provided an image showing applied pressure to the irrigation tubing by lifting the entire irrigations tubing upward toward the cassette resulting in a kink near the cassette.The laboratory was able to recreate the same kink by inducing the same pressure, when the tubing was released, the kink went away (the tubing should hang freely from the cassette).The customer should be reminded the directions for use stipulates good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.In returned condition, the wet tubing on the cassette did not exhibit any kinks and the irrigation tubing was measured and found to be conforming to specifications.A calibrated console was used to sample and the cassette primed and tuned with the ultrasonic handpiece successfully and could achieve maximum vacuum.No system message was generated, no fluid or air leaks, and no cracks were observed on the connectors that would have contributed to the reported event.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the balanced salt solution (bss) bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No occlusion or obstruction was observed during inspection and functional testing.The root cause of the customer's complaint could not be established as the returned cassette was evaluated and met specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.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: 8947454
• MDR Text Key: 156300584
• Report Number: 2028159-2019-01593
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK; INFINITI SURGICAL PROCEDURE PAK