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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, HANDPIECE; UNIT, PHACOFRAGMENTATION

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number ASKU
Device Problems Inability to Irrigate (1337); Overheating of Device (1437)
Patient Problem Eye Burn (2523)
Event Date 01/16/2024
Event Type  Injury  
Event Description
A physician reported an incident during surgery where irrigation failure led to a thermal burn experienced by the patient.Upon investigation, it was discovered that the ophthalmic viscosurgical device had accumulated within the irrigation sleeve.Additionally, the surgeon confirmed that the ultrasound tip was pressed against the wound wall to stabilize the eyeball, causing frictional heat generation between the tip and sleeve due to ultrasound transmission.This resulted in insufficient cooling of the tip due to inadequate irrigation fluid flow, leading to the burn.Postoperatively, the thermal burn was treated with steroidal ointments, antibiotics, and nonsteroidal anti-inflammatory drugs.However, the patient discontinued the steroid ophthalmic ointment independently, leading to a worsening of symptoms despite initial improvement.Despite the complication, the surgery was successfully completed on the same day.This report pertains to phacoemulsification handpiece involved in this reported event.
 
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
Specific product identifiers (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 serial number cannot be performed as the serial number is unknown.The serial is unknown; therefore, a service history review cannot be performed.Based on the information available, the customer reported event cannot be confirmed.The customer reported event cannot be confirmed.Based on the information obtained, the root cause of the reported event is inconclusive.The root cause of the reported event is inconclusive.Therefore, no further actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Receipt of complaint sample or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CENTURION VISION SYSTEM, ACCESSORY, 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 Key18701600
MDR Text Key335296097
Report Number2028159-2024-00229
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeJA
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 Physician
Type of Report Initial,Followup
Report Date 05/10/2024
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? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/16/2024
Initial Date FDA Received02/14/2024
Supplement Dates Manufacturer Received04/12/2024
Supplement Dates FDA Received05/10/2024
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 Number1
Treatment
CENTURION SURGICAL PROCEDURE PAK; LINDELON; NEBANAC; NEOMEDROL; VEGAMOX; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
Patient Outcome(s) Required Intervention; Other;
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