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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS Back to Search Results
Model Number DAT015
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code 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.There have been no other complaints reported in the lot number.Sample device was not returned for analysis.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A facility representative reported that post implantation of an intraocular lens (iol) the patient experienced starbursts at night.The iol was exchanged in a secondary procedure approximately 2 months following the initial procedure.
 
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Brand Name
ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key12302414
Report Number1119421-2021-01540
Device Sequence Number5096958
Product Code POE
UDI-Device Identifier00380652424561
UDI-Public00380652424561
Combination Product (Y/N)N
Initial Reporter StateFL
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
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/10/2021
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 Date09/17/2025
Device Model NumberDAT015
Device Lot Number15099553
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/21/2021
Initial Report FDA Received Date08/10/2021
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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