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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL Back to Search Results
Model Number TFAT30
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Blurred Vision (2137)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Evaluation summary: 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.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A health care professional reported that an intraocular lens (iol) was explanted one week after implantation due to blurred vision.Additional information has been requested.
 
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Brand Name
ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
Common Device Name
LENS, MULTIFOCAL
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key11712705
Report Number1119421-2021-00879
Device Sequence Number4026438
Product Code MFK
UDI-Device Identifier00380652418690
UDI-Public00380652418690
Combination Product (Y/N)N
Initial Reporter StateCA
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
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 04/22/2021
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 Date02/02/2025
Device Model NumberTFAT30
Device Catalogue NumberTFAT30.195
Device Lot Number15021604
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/01/2021
Initial Report FDA Received Date04/23/2021
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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