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

Model Number	DFT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced bad glare at night, also have halos surround any light at night which makes driving very difficult and have a hard time focusing on close objects and reading smaller print.Patient can see the edges of the lenses at all times, and they seem to flash and as per surgeon it was peripheral vision stretching, however nothing has improved.The surgeon said that eyes would need time to adjust since patient have very blurry vision after 4 feet.Additional information was provided stated that patient had a bad glare all the time and was very comparable to wearing an extremely dirty pair of glasses that are covered in finger prints.Patient see the sides of the lenses all the time and they seem to pulsate when patient try to look at an object.On (b)(6) 2022, consumer had the yag laser treatment and eyes didn¿t improve.Consumer not able to read the speedometer or print.No further information available.Additional information received and stated that after surgery patient need glasses for driving and has night time halos and the outcome was more myopic than predicted, and has fully functional vision with minor residual myopia.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
On initial mdr the h.10, and evaluation method code of 4119 was an error.It should have been 4114 on the original mdr.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 number.Information was provided that the patient reported surgeon recommended time to allow patient to adjust to lens.Patient has been prescribed glasses for driving.Additional information was provided that the surgeon reported the patient, "now has fully functional vision albeit with minor residual myopia.(b)(4) of patients with these entering problems would have been delighted with this outcome." surgeon reported giving the patient a refund.Patient is seeking a referral from surgeon for a new doctor.No further information has been provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION 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: 14337454
• Report Number: 1119421-2022-00977
• Device Sequence Number: 17706389
• Product Code: POE
• UDI-Device Identifier: 00380652421669
• UDI-Public: 00380652421669
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 03/29/2026
• Device Model Number: DFT315
• Device Lot Number: 15178776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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
• Patient Age: 38 YR
• Patient Sex: Male