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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 Malposition of Device (2616)
Health Effect - Clinical Code Visual Impairment (2138)
Type of Reportable Event Serious Injury
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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A facility representative reported that after the initial intraocular lens (iol) implant procedure, a patient complained of "poor vision" and a clinical reason of "poor centration".This required the removal of the iol in a secondary surgery.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 Key11752686
Report Number1119421-2021-00933
Device Sequence Number19868168
Product Code MFK
UDI-Device Identifier00380652414807
UDI-Public00380652414807
Combination Product (Y/N)N
Initial Reporter StateNY
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) 04/30/2021
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? No
Operator of Device Health Professional
Device Expiration Date02/29/2024
Device Model NumberTFNT00
Device Catalogue NumberTFNT00U105
Device Lot Number12693857
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/06/2021
Initial Report FDA Received Date04/30/2021
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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