MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065752914

Device Problem Obstruction of Flow (2423)

Patient Problems Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/29/2021

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 customer reported that during a surgery an ophthalmic operating console (system) was not aspirating and the phacoemulsification handpiece (hp) was occluded during sculpt mode.The patient experienced a corneal burn.Additional information has been received indicating the occlusion alarm was heard by the surgeon.The wound did not seal well so a suture was placed.This report represents hp involved in this event.

Manufacturer Narrative

Additional information was provided in sections b.5 and h.10.Corrected information was provided in d.10.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received indicating the patient was doing very well.

Manufacturer Narrative

Specific product identifiers (lot number, batch number, and/or serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.The root cause cannot be determined conclusively.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13086179
• MDR Text Key: 282766775
• Report Number: 2028159-2021-01532
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK; CENTURION VISION SYSTEM WITH ACTIVE SENTRY
• Patient Outcome(s): Other; Required Intervention