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

Model Number	DAT415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an post company lens vitrectomy to remove floaters in right eye, there was a mall obstruction in patient line of vision.Following various tests, including line of vision and even an mri, the retina and optic nerves were normal.Yet, the obstruction was there and moves with line of sight.By deduction, the lens might be defective.Additional information has been received there was an obstruction with line of sight of the right eye that moves with eye movement.The obstruction appears to be diagonally running between 8 and 6 o'clock (for better description), about a millimeter in width and 3-4 mm in length, shaped like a bean, and of light gray color.It moves up, down, left and right with direction of sight.Ended up performing a second vitrectomy on the assumption that the obstruction might be a remenance of a floater.Which was an additional layer of repeated emotional distress (given that my work necessities research, reading, computers, and typing), literally ineffective, for, the obstruction remains the same.
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 TORIC EXTENDED VISION UV ABSORBING 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: 20618391
• Report Number: 1119421-2024-02154
• Device Sequence Number: 20696380
• Product Code: POE
• UDI-Device Identifier: 00380652427937
• UDI-Public: (01)00380652427937(17)251007(11)201008(10)15105472
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: 10/07/2025
• Device Model Number: DAT415
• Device Lot Number: 15105472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 10/08/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown