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

Model Number	DFT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).H10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
An ophthalmic surgeon reported that after intraocular lens (iol) implantation, the patient experienced blurry vision, glare, pain and headaches.The lens was removed in a secondary procedure.The patient was unhappy after iol implantation was reported to be the clinical reason for explant.Additional information was requested, but no further information is available.
Event or Problem Description
Upon further review of the complaint, the patient had experienced blurry vision, glare, pain and headaches after lens implantation.The patient was unhappy after implantation.However, the lens was not explanted.
Additional Manufacturer Narrative
Upon further review of the complaint after submission of initial report, it was observed that the patient had experienced blurry vision, glare, pain and headaches after lens implantation.The patient was unhappy after implantation.However, the lens was not explanted.Thus, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 20053597
• Report Number: 1119421-2024-01620
• Device Sequence Number: 18142222
• Product Code: POE
• UDI-Device Identifier: 00380652421126
• UDI-Public: (01)00380652421126(17)260808(11)210810(10)15247489(21)15247489047
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 08/08/2026
• Device Model Number: DFT015
• Device Lot Number: 15247489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/20/2024
• Date Device Manufactured: 08/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown