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

Model Number	DAT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in a small blue plastic open container.Viscoelastic was observed on the lens.The optic was cut into two portions, typical in appearance to damage created to remove a lens from the eye.Each of the cut optic portions were cracked.Product history records were reviewed and documentation indicated the product met release criteria.The root cause cannot be determined for the reported complaint of "distorted vision, patient not happy, unable to see".The explanted lens was evaluated.The optic was cut into two portions, typical in appearance to damage created to remove a lens from the eye.Additional optic 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.Information was provided that the company 20.5 diopter (1.5 extended depth of focus) lens was removed and replaced with a non-company lens.The diopter of the replacement lens was not provided.No further information has been provided, if additional information becomes available, the file will be reopened and updated.The information that the extended depth of focus lens model was replaced with a monofocal lens model would suggest that the replacement lens was an improved selection for this patient's vision needs or preferences.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following intraocular lens (iol) implantation, patient had distorted vision and was unable to see.Patient was unhappy with the outcome.The lens was removed and replaced with another lens in a secondary procedure.According to additional information received, implantation was done in patient's right eye.The patient claimed that it appeared to be looking out of dirty contact.Iol exchange was done with another non-company lens.In the surgeon opinion the issue was not due to the product (iol).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING 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: 17660725
• Report Number: 1119421-2023-01537
• Device Sequence Number: 17918428
• Product Code: POE
• UDI-Device Identifier: 00380652424646
• UDI-Public: 00380652424646
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

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: 09/13/2025
• Device Model Number: DAT015
• Device Lot Number: 15098244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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: MONARCH II IOL DELIVERY SYSTEM, INJECTOR; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female