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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ RESTOR SINGLEPIECE IOL; LENS, MULTIFOCAL INTRAOCULAR
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ RESTOR SINGLEPIECE IOL; LENS, MULTIFOCAL INTRAOCULAR Back to Search Results
Model Number SN6AD1
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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision at distance due to residual myopia.The lens was exchanged for a different lens within 1 month after initial implantation.
 
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Brand Name
ACRYSOF IQ RESTOR SINGLEPIECE IOL
Common Device Name
LENS, MULTIFOCAL INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key12231119
Report Number1119421-2021-01467
Device Sequence Number3509632
Product Code MFK
UDI-Device Identifier00380652241717
UDI-Public00380652241717
Combination Product (Y/N)N
Initial Reporter StateFL
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) 07/27/2021
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 Date07/31/2023
Device Model NumberSN6AD1
Device Lot Number12644742
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/29/2021
Initial Report FDA Received Date07/27/2021
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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