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

Catalog Number 8065750833

Device Problem Material Rupture (1546)

Patient Problems Rupture (2208); Collapse (2416)

Event Date 11/07/2019

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 surgeon reported that during a cataract with intraocular lens implant (iol) procedure there was continuous irrigation even with the footpedal not depressed.During the cortex removal the irrigation stopped and the anterior chamber shallowed and then collapsed.The probe touched the posterior chamber causing a rupture that required an anterior vitrectomy to repair.

Manufacturer Narrative

Additional information is provided in g.1., g.2., h.6.And h.10.Posterior capsule (pc) tear is a potential consequence of cataract extraction by phacoemulsification.Predisposition to pc tear or zonular dehiscence can be influenced by many factors including, but not limited to, congenital posterior lenticonus, posterior sub capsular (psc) cataract, poor visibility secondary to patients comorbidity [ie.Dense arcus, pterygium, band keratopathy, corneal scars, interstitial keratitis], poor microscope illumination [red reflex], ergonomic obstacles, limited intraocular working space, abnormally long or short axial lengths, pseudoexfoliation, zonular laxity, poor dilation, intraoperative floppy iris syndrome (ifis), dense cataracts, asteroid hyalosis, or inadvertent patient movement.The conditions that increase the risk of pc tear during phacoemulsification include ergonomic obstacles, limited intraocular working space, poor visualization, increased nuclear size and density, weakened zonule, a radial tear in the capsulorhexis, and an inability to rotate the nucleus or epinucleus.These conditions may arise either because of the ocular anatomy, or because of surgical technique.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 non-company surgical reusable or disposable i/a handpieces that do not meet company surgical specifications, or use of a company handpiece not specified for use with the vision 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 vision 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).With the lack of information, there is no evidence contained within the reported information at this time that indicates that the design or performance of the system had any effect on the integrity of the posterior capsule.The company service representative called the customer to assist with troubleshooting.The customer was able to troubleshoot and the problem reported was not duplicated.The system functioned as intended.The customer did not request service.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.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: 9440649
• MDR Text Key: 170006328
• Report Number: 2028159-2019-02201
• 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
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR