MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; PHACOFRAGMENTATION SYSTEM

Model Number INFINITI

Device Problems Restricted Flow rate (1248); Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2013

Event Type  malfunction  

Event Description

A customer reported two cases where the cassette tubing was crushed while in the pack.The products were used for two separate cataract procedures.However, during the surgeries, it was noted that there was insufficient fluid flow.The products were replaced and the procedures were completed w/o consequences to the pts.No add'l details are available for this report.

Manufacturer Narrative

The returned samples were visually inspected and kinks were observed in the tubings.Sample #1 had a kink, located in the administration and irrigation tubing below the cassette insertion.Sample #2 had a kink located 5" from the cassette insertion in the administration and irrigation tubing.A console representing a current software version was used to test both samples.The samples could prime and tune successfully.Fluid flowed from the bss bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No message codes, fluid leaks or air leaks were observed and no cracks on the luers were found on either sample.The irrigation and aspiration flow rates were also measured and found to be within specification.The customer's complaint of kinked tubing was confirmed, however the sample performed to specification during functional testing.The root cause of the kinks could not be determined based on the info available to date.(b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: PHACOFRAGMENTATION SYSTEM
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3721109
• MDR Text Key: 15271116
• Report Number: 2028159-2014-00410
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFINITI
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2013
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: MF 45K; INF US PAK; 0.9MM