Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Blurred Vision (2137)
Date of Event 05/04/2021
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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A facility representative reported that following implantation of an intraocular lens (iol) the patient experienced blurred vision affecting quality of life.The lens was explanted.Additional information was requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11889986
Report Number1119421-2021-01109
Device Sequence Number1284696
Product Code POE
UDI-Device Identifier00380652424639
UDI-Public00380652424639
Combination Product (Y/N)N
Initial Reporter StateSC
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) 05/26/2021
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 Date09/15/2025
Device Model NumberDAT015
Device Lot Number15099689
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/06/2021
Initial Report FDA Received Date05/26/2021
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;
Patient Age51 YR
-
-