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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS Back to Search Results
Model Number DFT415
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
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 has been 1 other complaint for the lot.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision due to iol power.The iol was exchanged with another iol model, 42 days after following the initial implant procedure.Additional information has been requested; however, further information has not been received.
 
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Brand Name
ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key12751940
Report Number1119421-2021-02063
Device Sequence Number16504363
Product Code POE
UDI-Device Identifier00380652422031
UDI-Public00380652422031
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
P930014
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 Nurse
Type of Report Initial
Report Date (Section B) 11/04/2021
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 Date06/10/2025
Device Model NumberDFT415
Device Lot Number15075184
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/13/2021
Initial Report FDA Received Date11/04/2021
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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