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

Model Number	DAT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
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 non-healthcare professional reported that after intraocular lens (iol) implantation, the patient still had glare, and vision was not as crisp.The lens was removed and replaced with a non-company lens in a secondary procedure.The clinical reason for explant was cited as mild residual refractive error.According to the additional information received, in the surgeon's opinion, the product was responsible for the patient's events, the patient experienced ghosting and blurry vision since initial procedure.The patient's symptoms were resolved, and the surgeon reported a good prognosis.There was no further impact to the patient.
Additional Manufacturer Narrative
Additional information provided in sections d.9., h.3., h.6., and h.11.The lens was returned inside a plastic specimen jar.Solution was dried on the lens.The optic was cut into two portions with serrated edges.The optic portions were returned.One haptic was broken in the haptic/optic junction.The broken haptic portion was not returned.It is unknown if a qualified cartridge and handpiece were used.The customer indicated it was unknown if a company cartridge or handpiece was used.A non-qualified viscoelastic was used.The product investigation could not determine the root cause for the reported vision complaint.The explanted lens was returned and evaluated.The optic was cut with serrated edges into two portions and broken haptic damage was observed.Each lens was subjected to a 100% 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.The company toric (1.50 cyl.) 18.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a non-company monofocal non-toric 17.5 diopter lens.Due to the exchange of a company toric lens model for a non-company monofocal non-toric lens, and a difference of 0.5 less diopters for the replacement lens, this may suggest that a monofocal non-toric lens of a lesser diopter was an improved selection for this patient's vision needs.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; 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: 23934655
• Report Number: 1119421-2025-03305
• Device Sequence Number: 5609690
• Product Code: POE
• UDI-Device Identifier: 00380652427050
• UDI-Public: (01)00380652427050(17)250423(11)200424(10)15038977
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 04/23/2025
• Device Model Number: DAT315
• Device Catalogue Number: DAT315.180
• Device Lot Number: 15038977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEALON PRO.; MONARCH II LOADING FORCEPS.; ORA SYSTEM WITH VERIFEYE MESSAGING.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male