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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, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065752914
Device Problem Particulates (1451)
Patient Problems Corneal Scar (1793); Blurred Vision (2137); Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/06/2021
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.(b)(4).
 
Event Description
A physician reported that during surgery the patients were experienced with corneal burn due to high thermal energy which caused wound leak, corneal opacity, scar interfering with visual axis, corneal astigmatism.The scar required four sutures as surgical intervention and operator observed a white virus at the end of the tip.The procedure was completed.
 
Manufacturer Narrative
The phaco handpiece was not returned for evaluation.A phaco handpiece 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 lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.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).
 
Manufacturer Narrative
Additional information has been provided in sections d.9, h.3, h.6 and h.10.The phacoemulsification handpiece was received for this investigation.A visual assessment of the returned sample revealed a missing red dot.The 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.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.Most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.The returned phaco hp met specification.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).
 
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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 Key13382420
MDR Text Key284609169
Report Number2028159-2022-00092
Device Sequence Number1
Product Code HQC
UDI-Device Identifier00380657529148
UDI-Public00380657529148
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
K161794
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/10/2023
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 Number8065752914
Device Lot Number140PMX
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received01/28/2022
Supplement Dates Manufacturer Received04/22/2022
01/18/2023
Supplement Dates FDA Received04/29/2022
02/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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