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

Model Number	DFT315
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that, the implanted lens has an error or manufacturing defect with respect to the diopters that it corrects or has been carved, either in the toric part, spherical or both.Additional information has been received stating that, lens implanted with refractive residual that a priori attends to rotation of the lens.Also, the patient is not seeing, and the residual refraction is -1.25 (+1.50).There is patient impact and the patient's symptoms is still continuing.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.No specifics were provided.The lens remains implanted.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the lens was at the intended calculated axis.It is unclear if the initial report of "rotation of lens" referred to a lens repositioning.File will be reopened if new information/clarification is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating that the lens was initially positioned at the correct angle and was not deviated and explanted.

• 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: 18737112
• Report Number: 1119421-2024-00302
• Device Sequence Number: 20641343
• Product Code: POE
• UDI-Device Identifier: 00380652421591
• UDI-Public: 00380652421591
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Model Number: DFT315
• Device Lot Number: 15244660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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 Age: 58 YR
• Patient Sex: Male