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

Model Number	DFT415
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Diplopia/Double Vision (4802)
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 healthcare professional reported that following cataract surgery with intraocular lens (iol) implant procedure, the patient had complained of double vision, monocular shadowing, and blur.The lens was exchanged with another lens 1 month and 25 days after the initial implant procedure.The clinical reason was defective lens.Additional information received stating that surgeons opinion product contributed to event.
Event or Problem Description
Additional information received stating that patient had corneal edema post operation.Additional information received stating that the patient the still had cornea edema two weeks post operation.Edema probably due to second surgery for lens removal.Patient was on hypertonic sodium chloride eye drops.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.A qualified cartridge and viscoelastic were indicate with a non-qualified handpiece.This would not be relevant to the reported visual issues.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100 percent 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 company (2.25cyl), 18.5 diopter was replaced with company (1.50cyl), 19.0 diopter lens.The change in cylinder and spherical power may indicate the replacement les was an improved choice for the patient's visual needs.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; 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: 19973688
• Report Number: 1119421-2024-01560
• Device Sequence Number: 8460716
• Product Code: POE
• UDI-Device Identifier: 00380652422024
• UDI-Public: (01)00380652422024(17)250219(11)200221(10)15039035
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2025
• Device Model Number: DFT415
• Device Lot Number: 15039035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/16/2024; 10/06/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/13/2024; 10/29/2024
• Date Device Manufactured: 02/21/2020
• 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: ACRYSOF IQ VIVITY TORIC IOL.; CLAREON MONARCH IV INJECTOR.; MONARCH III CARTRIDGE D.; MURO 128 DROPS.; PROVISC.; STANDARD LENS FOLDER FORCEP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female