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

Catalog Number 8065751763

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Burn, Thermal (2530)

Event Date 03/26/2018

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

An ophthalmic surgeon reported that during a cataract extraction with intraocular lens implant procedure the patient experienced detachment of descemet¿s membrane, suspected burn of the incision.Additional information has been requested but not received.

Manufacturer Narrative

The surgeon attributes the thermal injury to the phaco tip (which was not kept for evaluation examination).The surgeon also confirms that the astigmatism was a result of the thermal injury as well.There was no service requested for this event.Additional information was requested but was not provided by the customer.Descemet¿s membrane tearing/wrinkling is often attributable to surgical procedures, and is usually confined to the incision site.Early in the postoperative period, patients can be asymptomatic, and clinical signs might be difficult to detect.When apparent, descemet¿s membrane tears and detachments may cause decreased vision and corneal edema in the first days or weeks after surgery.Known risk factors that may increase the likelihood of traumatic entry into the anterior chamber include oblique angle of entry, anterior and shelved incisions, use of a blunt knife, injection of viscoelastic or antibiotics anteriorly to descemet¿s membrane, a shallow anterior chamber, soft eye, previous surgery, and recent episode of corneal edema.Corneal thermal injuries are typically related to excessive heat generated by the phaco tip due to insufficient aspiration flow, extended energy application, or combination of both.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.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the (b)(6) patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.There is insufficient information regarding the patient¿s ocular history and detailed events surrounding the occurrence.Instructing patients to avoid eye rubbing or any other type of trauma to the cornea should always be emphasized after intraocular surgery.The system was manufactured on october 16, 2014.Based on qa assessment, the product met specifications at the time of release.The balanced phaco tip was not returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified; therefore, a lot history review could not be conducted.Phaco tips are 100% visually inspected by trained operators during the manufacturing process.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION 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: 7439250
• MDR Text Key: 105755603
• Report Number: 2028159-2018-00783
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Other Device ID Number: 380657517633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2014
• 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