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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Clouding/Hazing (1878); Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/26/2021
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported that a patient experienced mild corneal burn at the beginning of cataract extraction procedure.The surgeon noticed a white plume then he immediately stopped and flushed phacoemulsification tip.The patient was treated with suture and corneal glue.The patient's corneal burn resulted in trace corneal opacity.The patient's experienced persistent wound leakage two weeks after the surgery.The patient was referred to a corneal specialist.The patient symptoms are continuing.
 
Manufacturer Narrative
The company service representative examined the system and was unable to confirm or replicate the reported event.The system was then tested and met all product specifications.A system 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.The system 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).
 
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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 Key12927171
MDR Text Key281728924
Report Number2028159-2021-01440
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/16/2022
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? Yes
Initial Date Manufacturer Received 11/15/2021
Initial Date FDA Received12/03/2021
Supplement Dates Manufacturer Received01/26/2022
Supplement Dates FDA Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MALYUGEN RING.; OZIL TORSIONAL HANDPIECE.; RESURE GLUE.
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient SexMale
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