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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF RESTOR UV ABSORBING MULTIFOCAL +2.5 IOL; LENS, INTRAOCULAR
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF RESTOR UV ABSORBING MULTIFOCAL +2.5 IOL; LENS, INTRAOCULAR Back to Search Results
Model Number SA25T0
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Visual Disturbances (2140); Halo (2227)
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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure the patient experienced glare and halos at night.The iol was exchanged in a secondary procedure for clinical reason of glare and halos at night.Additional information was requested.
 
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Brand Name
ACRYSOF RESTOR UV ABSORBING MULTIFOCAL +2.5 IOL
Common Device Name
LENS, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key11973058
Report Number1119421-2021-01187
Device Sequence Number3604449
Product Code MFK
UDI-Device Identifier00380652344395
UDI-Public00380652344395
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P040020
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/10/2021
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 Date05/31/2023
Device Model NumberSA25T0
Device Lot Number12625348
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/20/2021
Initial Report FDA Received Date06/10/2021
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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