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); Visual Impairment (2138); Shaking/Tremors (2515)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, lens was explanted in secondary procedure due to refractive error, headache, tremor.Patients symptoms resolved after lens exchange.Additional information was requested.Pre-op measurements: bcva (include date): 26-jun-2024 -8.25 / -0.5 / 31 degree /1.0 mrx (include date): -6.50 /-0.25 / 2 / 1.0 on 26-apr-2024 previous contact lens use within the last year: no.Post-op measurements: ucva (include date): 1.0 bcva (include date): 1.2 mrx (include date): +0.75 / -0.50 / 61 degree on 22-nov-2024.
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).

• 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: 21068303
• Report Number: 1119421-2025-00057
• Device Sequence Number: 12855296
• Product Code: POE
• UDI-Device Identifier: 00380652421157
• UDI-Public: (01)00380652421157(17)280715(11)230718(10)15682767
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

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 Model Number: DFT015
• Device Lot Number: 15682767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 07/18/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male