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

Model Number	DAT515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
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 facility representative reported following an intraocular lens (iol) implant procedure, the patient visual acuity was significantly worse than od.The lens was explanted and replaced with non-company monofocal lens in a secondary procedure.The clinical reason for the explant was mentioned as patient unable to adapt to ef iol.Replaced with monofocal iol.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned inside a non company lens case placed into a clear plastic bag.Viscoelastic was dried on the lens.The optic was cut into two portions, typical in appearance to damage from insertion and removal.The two portions were returned atop one another in the non company lens case.A post of the lens case has torn, split, and cracked one of the optic portions.A power and resolution recheck could not be conducted due to the extreme lens damage.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Associated product information was not provided.The product investigation cannot determine the root cause for the reported complaint.The lens was returned cut into pieces, typical of an insertion and removal.The transport lens case has further damaged the lens.Each lens is subjected to a 100percentage 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.The power and resolution of the returned lens could not be re evaluated due to the optic damage.The toric company lens 21.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a non-company monofocal lens (22.0 diopter).Due to the exchange of an extended depth of focus toric lens (21.0 diopter) for a non-company monofocal lens (22.0 diopter), this may suggest that a monofocal lens of a higher 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: 21934635
• Report Number: 1119421-2025-01231
• Device Sequence Number: 12098059
• Product Code: POE
• UDI-Device Identifier: 00380652428750
• UDI-Public: (01)00380652428750(17)250317(11)200318(10)15057730
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: 03/17/2025
• Device Model Number: DAT515
• Device Catalogue Number: DAT515.210
• Device Lot Number: 15057730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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 Sex: Unknown