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 Code	Visual Impairment (2138)
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).
Event or Problem Description
A nurse reported that after surgery the patient experienced discomfort.So, the lens was exchanged in the secondary implant procedure.Additional information was received and stated, the patient only experienced discomfort and no vision.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The lens was returned inside a cylindrical tube.A purple lid (r) was on one end of this container and a white lid (l) was on the opposite end.The lens was removed to evaluate.The optic was cut into two pieces, typical of an insertion and removal.One optic portion was cracked on the anterior optic surface near the edge.The posterior optic surface has a small cracked area near the edge.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.The product investigation could not identify a root cause for the reported complaint.The lens was returned cut into pieces, typical of an insertion and removal.The optic had additional damage.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided that the company (1.50cyl), 24.0 diopter, (1.5 extended depth of focus) lens was replaced with an unspecified lens model.Additional information was provided the initial lens was implanted on (b)(6) 2021 and explanted on (b)(6) 2023.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21936448
• Report Number: 1119421-2025-01247
• Device Sequence Number: 12733638
• Product Code: POE
• UDI-Device Identifier: 00380652421720
• UDI-Public: (01)00380652421720(17)260303(11)210305(10)15158210
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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 Expiration Date: 03/03/2026
• Device Model Number: DFT315
• Device Catalogue Number: DFT315.240
• Device Lot Number: 15158210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• 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