MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.There were no other complaints reported in the lot number.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following implantation of an intraocular lens patient experienced cloudy vision, film, blurred vision, severe glare.The lens was exchanged with a new one in a secondary procedure.Additional information was requested and received reporting that in surgeons opinion mechanical complication, severe glare and blurred visual acuity caused or contributed to the event.There was no patient harm.
Additional Manufacturer Narrative
The lens was returned adhered to/pressed between two plastic cups.Solution was dried on the lens.The lens was cleaned with lphse, for further evaluation.The optic has a large deep crack in the central optic zone of the lens.Other than the damage, the lens appears clear.Power and resolution testing could not be conducted, due to the extensive optic damage.Qualified associated products were indicated.The product investigation could not identify, a root cause for the reported complaint.Power and resolution testing could not be conducted, due to the extensive optic damage.The power and resolution of each lens is 100% evaluated, during the manufacturing process to determine acceptability per model and diopter.Information was provided in the file, that the multifocal toric 19.5 diopter (3.75cyl), add power +2.2 & 3.2 lens model was replaced with a monofocal toric (3.75cyl), 19.0 diopter lens model.Due to the exchange of a multifocal lens to a monofocal lens, this may suggest, that the replacement lens model was an improved choice for the patient's vision needs.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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 ; 8175514979
• MDR Report Key: 12703513
• Report Number: 1119421-2021-02000
• Device Sequence Number: 13820114
• Product Code: MFK
• UDI-Device Identifier: 00380652420280
• UDI-Public: 00380652420280
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 07/31/2024
• Device Model Number: TFAT60
• Device Catalogue Number: TFAT60.195
• Device Lot Number: 12732232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• 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: ACRYSOF SP IOL; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC; ACRYSOF SP IOL; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female