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

Model Number	DAT415
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
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision.The iol was scheduled to be explanted (b)(6) 2021.Additional information has been requested and received sated that the lens was explanted in a secondary procedure and a replacement lens was implanted.
Additional Manufacturer Narrative
The product was not returned.All product and batch history records are quality reviewed prior to product release.The customer indicated the use of a qualified monarch cartridge and company hand piece.The customer indicated the use of a viscoelastic, which is not qualified for monarch cartridge use.The product investigation could not identify a root cause for the reported complaint.Information was provided that the 20.0 diopter (1.5 extended depth of focus) lens was replaced with an lens (2.25cyl), 21.0 diopter lens due to blurred vision and mechanical complication of the lens.The iol does not have a mechanical component--the terminology used to report mechanical complication is an insurance coding term that is used for billing and coding when a lens is exchanged---the verbiage does not indicate a lens malfunction.The product was not returned to evaluate.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned, positioned incorrectly in the lens case.Solution was dried on the lens.The optic is cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted, due to the extensive optic damage.The power and resolution of each lens is 100% evaluated, during the manufacturing process to determine acceptability per model and diopter.There have been no other complaints reported in the lot number.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; 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: 12982608
• Report Number: 1119421-2021-02351
• Device Sequence Number: 14888946
• Product Code: POE
• UDI-Device Identifier: 00380652427944
• UDI-Public: 00380652427944
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 07/26/2025
• Device Model Number: DAT415
• Device Lot Number: 15085761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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 TORIC SINGLEPIECE IOL; AMVISC PLUS; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male