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

Catalog Number 8065750833

Device Problems Use of Incorrect Control/Treatment Settings (1126); Unstable (1667)

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

Event Date 11/28/2017

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 healthcare professional reported that the surgeon's settings had been changed, there was no vacuum in the quadrant mode.The patient's capsule was unstable during a surgical procedure.Additional information has been requested.

Manufacturer Narrative

The surgeon reports ¿chamber instability during cases.Also the settings have changed.When in quadrant mode the pieces don't come to the surgeon and the capsule is unstable.¿ additional, related information was not provided by the surgeon.The operators manual states if the handpiece test chamber is collapsed after tuning, there is a potential of low irrigation flow through the handpiece and may result in a fluidic imbalance.This, in turn, may cause a shallowing or collapsing of the anterior chamber.The operators manual also warns the use of surgical reusable or disposable i/a handpieces that do not meet surgical specifications, or use of an alcon handpiece not specified for use with the system, may result in a fluidic imbalance.This, in turn, may cause a shallowing or collapsing of the anterior chamber.Exceeding the recommended level of 100 mmhg with a 0.5 mm or larger i/a tip may cause anterior chamber shallowing and/or incarceration or tearing of the posterior capsule.Anterior chamber stability is primarily influenced by the balance between influx of irrigating fluid and its efflux through the main corneal incision and side ports.The system is designed to cool the phaco tip during use as aspirated fluid flows through the tip lumen.Overheating of the phaco tip, however, may occur due to extended application of ultrasonic energy or compromised aspiration flow through the phaco tip.Reduced fluid flow through the phaco tip may be caused by phaco tip re-use, tip clogging by nuclear material, kinked tubing, inadequate flow and vacuum settings, or obstruction by ophthalmic viscoelastic device (ovd).When the phaco tip is occluded, infusion will cease, reducing the cooling effect of the tip.Occlusion tones (intermittent beeping tones during occlusion) alert the user, indicating that the vacuum is near or at its preset limit, and aspiration flow is reduced or stopped.The surgeon must recognize the occlusion tones and manually stop the ultrasound mode in order to prevent a rapid temperature increase and or chamber collapse.As the patient¿s medical or ocular history were not provided, it is unknown if the patient had preexisting comorbidity that would predispose chamber instability or intraoperative floppy iris syndrome (ifis).The company service representative examined the system and was not able to replicate the reported event.The system was then tested and met all product specifications.The system serial number (s/n) was not provided for the first system, and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The second system (s/n (b)(4)), was manufactured on october 25, 2011.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 event 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7127699
• MDR Text Key: 95690483
• Report Number: 2028159-2017-04547
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2011
• 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