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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; UNIT, PHACOFRAGMENTATION

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065751763
Device Problem Decrease in Suction (1146)
Patient Problem Capsular Bag Tear (2639)
Event Date 03/06/2023
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 cataract surgery an ophthalmic operating console not achieving vacuum.Patients were experienced with capsular bag integrity issue.Procedures were completed by replacing the handpiece and bottom ports were used.Surgeon performed sulcus intraocular lens and treated with carbamylcholine.Patient impact was not reported.
 
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).The system found to meet all cosmetic and performance standards.There was no samples retuned for testing on this investigation.Based on the information obtained, the root cause of the reported events is inconclusive.A non-conformance based review of the 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 events 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
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 Key16730168
MDR Text Key313187840
Report Number2028159-2023-00524
Device Sequence Number1
Product Code HQC
UDI-Device Identifier00380657517633
UDI-Public00380657517633
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121555
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/24/2023
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? No
Device Operator Health Professional
Device Catalogue Number8065751763
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2023
Initial Date FDA Received04/13/2023
Supplement Dates Manufacturer Received06/29/2023
Supplement Dates FDA Received07/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
OZIL TORSIONAL HANDPIECE.
Patient Outcome(s) Other; Required Intervention;
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