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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TRIFOCAL IOL; LENS, MULTIFOCAL
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TRIFOCAL IOL; LENS, MULTIFOCAL Back to Search Results
Model Number TFNT00
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Visual Impairment (2138)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient had a refractive error and was unhappy with vision.The iol was exchanged in a secondary procedure.Additional information has been requested.
 
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Brand Name
ACRYSOF IQ PANOPTIX TRIFOCAL IOL
Common Device Name
LENS, MULTIFOCAL
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key11631507
Report Number1119421-2021-00766
Device Sequence Number17060797
Product Code MFK
UDI-Device Identifier00380652415071
UDI-Public00380652415071
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P040020
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Reporter Type Manufacturer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/07/2021
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
Operator of Device Health Professional
Device Expiration Date01/31/2024
Device Model NumberTFNT00
Device Catalogue NumberTFNT00U240
Device Lot Number12690993
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/17/2021
Initial Report FDA Received Date04/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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