MAUDE Adverse Event Report: ALCON RESEARCH, LLC ACRYSOF IQ VIVITY IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DFT015
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Headache (1880); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dear sir i have cataract surgery as on (b)(6) 2023.Doctor of (b)(6) has placed acrysof iq vivity iol sn (b)(6.After surgery i have got the following complications- 1 ring around the source of light in night even though company claim there ring should not in case of iol lenses.2.Headache 3.Heaviness surrounding the eye.4.Feeling something preventing vision like a membrane.3 unable to open eye continuously.

• Brand Name: ACRYSOF IQ VIVITY IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 16888031
• Report Number: MW5117352
• Device Sequence Number: 20224311
• Product Code: POE
• UDI-Device Identifier: 00380652421232
• UDI-Public: 00380652421232
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DFT015
• Device Catalogue Number: DFT015.200
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2023
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: Asian