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

Model Number	DFT515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the reporter for further investigation.Further clarification was provided by the reporter (patient) that this was not a intended to be a complaint.The reporter wanted to query if it was possible that the body may be rejecting the implanted lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, vision was clearer but after one week, it turned foggy and the eye constantly segregates clear tears, which contributed to making blurred vision.Doctors prescribed nonsteroidal anti-inflammatory drugs and anti-allergic eye drops.Additional information has been requested.
Event or Problem Description
Additional information was received stating the initial procedure was cataract extraction with iol implantation and implant eye was right.The doctor's diagnosis was wait more or less 4 months from initial implantation and possibly perform a laser cleaning for adherences.
Additional Manufacturer Narrative
Product history records were reviewed and the documentation indicated the product met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided in b.5., and h.6 (fda patient code).Correction information has been provided in d.4.And h.6.(fda health impact code).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that, it had been almost three years since the intraocular lens implanted, still the patient was experiencing discomfort.The symptoms that were reported at the time of this report were the same as those at the beginning in (b)(6) 2022, but accentuated by time and vision fatigue.The vision was not clear, it was like glassy and somewhat shiny and the eye did not stop watering significantly, which makes vision more blurred.In night light the phenomenon seemed to decrease a little, but definitely the vision was very poor and affected.

• 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: 14675976
• Report Number: 1119421-2022-01254
• Device Sequence Number: 4818012
• Product Code: POE
• UDI-Device Identifier: 00380652422420
• UDI-Public: (01)00380652422420(17)251119(11)201120(10)15117570
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2025

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: 11/19/2025
• Device Model Number: DFT515
• Device Catalogue Number: DFT515_XXX
• Device Lot Number: 15117570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 02/07/2025
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/08/2022; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male