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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, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065751761
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2023
Event Type  malfunction  
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 a sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
 
Event Description
A nurse reported, that during the cataract surgery an ophthalmic handpiece was hot.The surgery was completed on the same day with another handpiece.There was no patient harm.
 
Manufacturer Narrative
The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, the phaco handpiece was returned for this investigation for testing.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.The phaco handpiece was received for this investigation for testing.A visual assessment of the returned sample revealed no obvious non-conformities.When the handpiece was connected to a calibrated breakout test box, the resistance and dissipation between low electrode and high electrode were both within specifications.The returned handpiece was connected to a calibrated system.The handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the hp was measured per the product design specification and was found to be within specifications.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specifications the handpiece was found to meet specifications.Therefore, 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).
 
Event Description
Additional information received via follow up indication the handpiece had displayed with error message where it could be completed the tunning process.
 
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Brand Name
CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL 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 Key16684658
MDR Text Key312822930
Report Number2028159-2023-00425
Device Sequence Number1
Product Code HQC
UDI-Device Identifier00380657517619
UDI-Public00380657517619
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K121555
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/28/2023
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 Number8065751761
Device Lot Number140UND
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/09/2023
Initial Date FDA Received04/05/2023
Supplement Dates Manufacturer Received06/05/2023
Supplement Dates FDA Received06/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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