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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 TFNT30
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
A sample device was not returned for analysis.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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A facility representative reported that four months following an intraocular lens (iol) implant procedure, the iol was exchanged for another lens due to poor vision/tolerance.Additional information has been requested.
 
Additional Manufacturer Narrative
Information was provided in the file that indicated the use of qualified associated products.An iol exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.The company lens (1.50cyl), 22.5 diopter (add power +2.2/+3.2) lens was replaced with a another company lens model, 24.5 diopter, (1.5 extended depth of focus) lens with a clinical reason for the explant of "poor vision/tolerance." the manufacturer internal reference number is: (b)(4).
 
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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 Key12364380
Report Number1119421-2021-01625
Device Sequence Number11746867
Product Code MFK
UDI-Device Identifier00380652390026
UDI-Public00380652390026
Combination Product (Y/N)N
Initial Reporter StateHI
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,Followup
Report Date (Section B) 11/02/2021
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 Date09/03/2025
Device Model NumberTFNT30
Device Catalogue NumberTFNT30.225
Device Lot Number15096625
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/04/2021
Supplement Date Received by Manufacturer10/05/2021
Initial Report FDA Received Date08/25/2021
Supplement Report FDA Received Date11/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ACRYSOF IQ VIVITY EXTENDED VISION IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; ACRYSOF IQ VIVITY EXTENDED VISION IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Outcome Attributed to Adverse Event Required Intervention;
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