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	Dry Eye(s) (1814); Headache (1880); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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-health care professional reported following the intraocular lens implantation the patient had experienced faint secondary image in each eye.When looking at a sign with light letters on a dark background, the image is to the left.When looking at a dark image on a light background, the image is to the right.Additional information has been received stating that a wrinkle on the cornea was observed for which drops were used to rule out any defect of the lens.It was further reported that the patient had experienced headache, eye pain and dry eye syndrome post surgery.The fait secondary image was clarified to be monocular double vision.Ibuprofen was used for eye pain and headache.
Additional Manufacturer Narrative
Based on clarification received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating the double image changes sides: to the left for light on dark, and to the right for dark on right in the right eye.Based on the information received it has been clarified that the previously reported events such as head ache, eye pain, using drops, are not related to the company lens.The wrinkle on the eye and the dry eye are considered to be prior to the surgery.Hence this file now does not meet criteria for reporting hence no further reports would be needed.Based on clarification received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.There are two medical device reports associated with this patient.This report is for the right eye.

• 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: 16822215
• Report Number: 1119421-2023-00785
• Device Sequence Number: 6709099
• Product Code: POE
• UDI-Device Identifier: 00380652427074
• UDI-Public: 00380652427074
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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: 10/06/2025
• Device Model Number: DAT315
• Device Lot Number: 15105498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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: #15 BLADE; BALANCED SALT SOLUTION; LIDOCAINE; PROVISC; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UTRATA FORCEPS; VISCOAT; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 64 KG