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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM (ACTIVE SENTRY); UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065753057
Device Problems Noise, Audible (3273); Suction Failure (4039)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/29/2023
Event Type  malfunction  
Event Description
A physician reported that during a cataract procedure an ophthalmic console displayed an error message, console had a strange noise, there was no aspiration in the quad mode.The patient had a anterior chamber collapse.The surgery was completed by restarting the console.
 
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).
 
Manufacturer Narrative
Service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.The system found to meet all cosmetic and performance standards.A non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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).
 
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Brand Name
CENTURION VISION SYSTEM (ACTIVE SENTRY)
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 Key16831751
MDR Text Key314174328
Report Number2028159-2023-00608
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161794
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065753057
Device Lot Number1395FE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2023
Initial Date FDA Received04/28/2023
Supplement Dates Manufacturer Received05/25/2023
Supplement Dates FDA Received06/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CENTURION SURGICAL PROCEDURE PAK
Patient SexMale
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