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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Bag Tear (2639)
Event Date 08/26/2021
Event Type  Injury  
Manufacturer Narrative
A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported that following a right eye cataract operation a lens was implanted and the surgeon noticed posterior capsule rupture. The surgeon explanted the lens and implanted a different lens which was found out to be unstable due to earlier complication. Hence the surgeon decided to explant the lens once again and implanted another lens with no further complications. Additional information has been requested.
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key12526144
MDR Text Key273118032
Report Number1119421-2021-01825
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAU00T0
Device Lot Number15080781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
Treatment
ACRYSOF MULTIPIECE IOL; ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
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