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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL; LENS, MULTIFOCAL
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL; LENS, MULTIFOCAL Back to Search Results
Model Number TFNT60
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Visual Impairment (2138)
Date of Event 05/10/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
A health care professional reported that following implantation of an intraocular lens (iol) the lens had glistening's.No information was provided about vision impairment.
 
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Brand Name
ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
Common Device Name
LENS, MULTIFOCAL
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key12153451
Report Number1119421-2021-01363
Device Sequence Number4817300
Product Code MFK
UDI-Device Identifier00380652391399
UDI-Public00380652391399
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
P040020
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date09/30/2023
Device Model NumberTFNT60
Device Catalogue NumberTFNT60.085
Device Lot Number12657702
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/21/2021
Initial Report FDA Received Date07/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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