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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 DFT315
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/05/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, significant iol rotation was noted at 1week of post operation.The patient is happy with vision.No secondary intervention is required at this stage.No further information is expected.
 
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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 Key12293868
Report Number1119421-2021-01530
Device Sequence Number3807508
Product Code POE
UDI-Device Identifier00380652421607
UDI-Public00380652421607
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P930014
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberDFT315
Device Lot NumberASKU
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date08/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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