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

Model Number V3.0

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Cut (2587)

Patient Problem Capsular Bag Tear (2639)

Event Date 09/20/2017

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.(b)(4).

Event Description

A customer reported that during a combined cataract procedure the patient experienced a posterior capsule tear in the right eye.An anterior vitrectomy was required and performed using another system.When the surgeon tried to use the vitreous cutter with the second system it did not cut.It was noted the system was set up for a 20 ga vitrectomy; however the staff had selected a 23 ga vitrectomy probe cutter.The case was completed.Additional information was requested and received.

Manufacturer Narrative

This is a (b)(6) year old male patient scheduled for surgery in the right eye (od).The primary issue reported was that the posterior capsule tore (pc tear) during a phaco procedure with an infiniti vision system.This resulted in the surgeon performing a vitrectomy (with the another system) to alleviate the pc tear issue.This is when the secondary issue was reported.The secondary issue reported was ¿the staff set up a 23g anterior vitrector.However, the device would not cut when placed in the eye.And the issue caused a delay of 1.5 hours, without harm to the patient.The company representative reviewed the set up that the staff had followed, and it appeared that they had left the device set up for a 20g prove rather than for a 23g cutter, resulting in a non-functioning cutter.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.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 root cause of the primary issue of (pc tear) cannot be determined conclusively.However, the second reported issue (cutting issues) are attributed to user error.The system was manufactured on february 6, 2013.Based on qa assessment, the product met specifications at the time of release.The vitrectomy probe was not returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a lot number history review could not be conducted.All vitrectomy probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.The root cause of the reported event 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, 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: 6944943
• MDR Text Key: 89264272
• Report Number: 2028159-2017-04051
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: V3.0
• Device Catalogue Number: 8065752160
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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): Required Intervention
• Patient Age: 65 YR