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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 Codes Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.No other complaints for lot.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure of the left eye, the patient was dissatisfied with the outcome.The patient experienced blurry vision, edge glare and negative dysphotopsia.The iol was exchanged in a secondary procedure.The patient's prognosis is good.
 
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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 Key12254088
Report Number1119421-2021-01498
Device Sequence Number14407334
Product Code MFK
UDI-Device Identifier00380652415613
UDI-Public00380652415613
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
Report Date (Section B) 07/30/2021
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 Date09/30/2024
Device Model NumberTFNT30
Device Catalogue NumberTFNT30U245
Device Lot Number12748824
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/06/2021
Initial Report FDA Received Date07/30/2021
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
MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; REP¿IOL: ZCB00, POWER:25.0, SN: (B)(4)
Outcome Attributed to Adverse Event Required Intervention;
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