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

Model Number	DAT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, the patient did not have perfect near vision and the patient is using reading glasses with 2.0 lenses to see anything.The doctor has confirmed that lenses are in perfectly and there are no issues except for the eyesight.The doctor also said that the patient falls under the small percentage of people for whom the lenses do not work.The issue with the eye sight start from the time of the surgery and the doctor has now performed yag procedure which improved the patent's vision by only 10 percent.There are two medical device reports associated with this patient.This report is associated with the right eye.Additional information has been requested.
Additional Manufacturer Narrative
The sample product was not returned.Complaint 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
Additional information was received stating that the patient had issues with blurry vision at all distances, the intraocular pressure has increased and an additional medication has been provided to reduce the increased intraocular pressure.Post operative 2 weeks, the intraocular pressure has been normalized and the drug has been stopped.The patient also feel foreign body sensation above the upper eye lid, and also sees shading sometimes.
Additional Manufacturer Narrative
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 and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the blurred vision is at intermediate and at near and associated with eye strain.The blurred vision is moderate in severity and is relieved by blinking.Patient has dry eye syndrome in both eyes.Surgeon encouraged more often use of eyedrops.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 17823207
• Report Number: 1119421-2023-01670
• Device Sequence Number: 14977592
• Product Code: POE
• UDI-Device Identifier: 00380652424561
• UDI-Public: 00380652424561
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/17/2023

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: 06/02/2026
• Device Model Number: DAT015
• Device Lot Number: 15211997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Female