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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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.There have been no other complaints reported in the lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following the cataract surgery with intraocular lens (iol) implant procedure, the patient could not see to drive at night and things were blurred.The patient can't see to read, using glasses, blurs things when she takes them off.There are two medical device reports associated with this event.This report is associated with the left eye.Additional information has been requested.
Additional Manufacturer Narrative
Non-qualified associated products were indicated, but would be unrelated to the reported events 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% 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 reporter (patient) was provided with the patient brochure with clinical study data and additional details on the vivity lens.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in b.6.And d.10.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: 15573760
• Report Number: 1119421-2022-02156
• Device Sequence Number: 2781387
• Product Code: POE
• UDI-Device Identifier: 00380652426985
• UDI-Public: 00380652426985
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2022

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: 07/06/2026
• Device Model Number: DAT315
• Device Lot Number: 15228686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 11/17/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/16/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: BARRETT.JNJ PLATINUM CARTRIDGE.; DUOVISC VISCOELASTIC SYSTEM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female