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 Code	Visual Disturbances (2140)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient's vision was not satisfactory, both up close, at intermediate distances, and at a distance.The patient had no useful quality of vision and was unable to read or drive due to these visual impairments.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.Additional information was provided that indicated the surgeon was uncertain why the patient couldn't see as clearly as desired.It was reported there was no planned lens exchange.The patient had prior lasik surgery.No further information has been provided at this time.File will be reopened when new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received from patient, it was started that her right eye was still not great and reading was only ok at arms length.

• 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: 17818548
• Report Number: 1119421-2023-01664
• Device Sequence Number: 15003971
• Product Code: POE
• UDI-Device Identifier: 00380652427050
• UDI-Public: 00380652427050
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

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: 07/06/2025
• Device Model Number: DAT315
• Device Lot Number: 15082302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/30/2023; 02/06/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/24/2023; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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: HAIGIS -L MYOPIC CALCULATOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OCUCOAT OVD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female