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

Catalog Number 8065750833

Device Problems Device Inoperable (1663); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2018

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.(b)(4).

Event Description

A customer reported that the vitrector did not work during a surgical procedure.The customer also indicated that the footpedal did not function.The system was exchanged and the same cutter was used to complete the surgery.There was no patient harm.

Manufacturer Narrative

The customer reported the anterior vitrectomy probe and foot pedal did not function.The customer brought in another system and was able to complete case.The same vitrectomy probe cutter was used and it worked fine.Additional information from the customer noted this occurred during surgery, but was not able to identify what specific step this occurred during.The customer was not able to state what type of procedure it was.The surgeon was able to complete the procedure by switching out the system.The customer stated no system message displayed.The customer stated there was no patient harm.The system is designed for use in anterior segment procedures that require simultaneous cataract lens extraction, irrigation, and aspiration, as well as associated procedures such as vitrectomy and coagulation.It was developed with a dual purpose: to make it simple to operate, and to allow the surgeon tremendous versatility and control.The system is designed to allow the surgeon to customize the treatment of every patient.One of the following key features of the system: ability to drive a high performance system vitrectomy guillotine cutter.The system vitrectomy probe, a guillotine vitreous cutter, is intended for single use only.The operator¿s manual includes the warning: do not test or operate vitrectomy probes unless tip of probe is immersed in bss sterile irrigating solution or distilled water or is in surgical use.Irreparable damage to the handpiece and tip can result if run dry.After filling and testing, and before surgical use, verify that the probe is properly actuating and aspirating.This may require lowering cut rate to achieve good visualization.The port should always remain in open position in foot pedal position 1.If cutting port is partially closed while in position 1, replace the probe.Prior to entry into the eye, and with tip of probe in sterile irrigating solution, the surgeon should step on the foot pedal for visual verification that the probe is cutting; alternatively, press the test button on the vitrectomy setup screen: if the cutter is observed to not fully close, or does not move when the probe is actuated, replace the probe.If cutting port is partially closed while idle, replace the probe.If air bubbles are observed in the aspiration line or exiting the probe tip during priming, replace the probe.If a reduction of cutting capability or vacuum is observed during the surgical procedure, stop immediately and replace the probe.The system was examined and the reported issue was not replicated.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on september 30, 2009.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported events cannot be determined conclusively.(b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7246439
• MDR Text Key: 99235906
• Report Number: 2028159-2018-00246
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Other Device ID Number: 8065750833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2009
• 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
• Patient Outcome(s): Other