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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 (ACTIVE SENTRY); UNIT, PHACOFRAGMENTATION

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM (ACTIVE SENTRY); UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065753057
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Corneal Clouding/Hazing (1878); Intraocular Pressure Increased (1937); Capsular Bag Tear (2639)
Event Date 05/11/2022
Event Type  Injury  
Event Description
A physician reported that during a cataract surgery sudden surge occurred which causes posterior capsule rupture.The surgery was completed without product replacement.Additional information has been requested none received till date.Additional information received indicating that the an imbalance between aspiration and irrigation flow and it was unknown whether any intervention performed for the posterior capsule rupture.Additional information received from the physician further clarified that tip was little loose and a vitreous clouding occurred due to posterior capsule rupture.Because of the residual vitreous clouding, the patient's outcome has not recovered.No additional treatment is planned and the patient is under observation.(surge caused posterior capsule rupture).
 
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
The company service representative examined the system and was unable to confirm or replicate the reported events of a tuning issue, surge, nor unbalanced irrigation and aspiration.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.A non-conformance based review of the batch/lot/serial number was performed and a potential contributing factor to the reported complaint was identified.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.There is no evidence that the design or manufacturing of the system contributed to the reported events.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 (ACTIVE SENTRY)
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 Key14595162
MDR Text Key293289940
Report Number2028159-2022-00722
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 09/06/2022
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 Number8065753057
Device Lot Number141VPL
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2022
Initial Date FDA Received06/03/2022
Supplement Dates Manufacturer Received08/10/2022
Supplement Dates FDA Received09/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
Patient SexFemale
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