MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.Associated product information was not provided.It is unknown if qualified associated products were used.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported following the intraocular lens implantation the patient had experienced headache, nausea and feeling off balanced.Systemic symptoms varied each day and none are ongoing, surgeon said she has posterior capsule opacification and will need a laser to clear the scar tissue.Additional information has been received stating symptoms have improved dramatically since having prk.The imbalance is gone and she is still healing.The symptoms have improved a lot.
Additional Manufacturer Narrative
Additional information provided in a.1., b.5., and b.7.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating patient is unhappy and have to wear glasses for almost all occasions which is not what she was promised by her surgeon.

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15867606
• Report Number: 1119421-2022-02489
• Device Sequence Number: 17814821
• Product Code: POE
• UDI-Device Identifier: 00380652421720
• UDI-Public: 00380652421720
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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 Date: 05/10/2025
• Device Model Number: DFT315
• Device Lot Number: 15070452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYSTANE COMPLETE QID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female