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

Model Number	TFAT50
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	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced poor vision and irregular astigmatism not able to diagnose before surgery.The iol was exchanged for another lens 1 month following the initial implant procedure.Additional information received and stated that the patient was not hospitalized for the event and there was no patient harm.
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Only a portion of the lens was returned for evaluation in a sealed non-company peel pouch.Solution was dried on the returned portion of lens.One haptic was cut from the haptic/optic junction area (not returned).The optic was cut and had a crack protruding near the cut damage.The observed damage is typical of insertion and removal.The other cut portion of lens including the other haptic was not returned for evaluation.Power and resolution testing could not be conducted due to the extensive optic damage.The file indicated the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.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.The file indicated that the multifocal 27.0 diopter (3.00cyl), add power +2.2 & 3.2 lens model was replaced with a non-company monofocal lens model.Information was provided that in the surgeon's opinion, the lens did not cause or contribute to the event.In surgeons opinion the "patient had irregular astigmatism, not able to diagnose before cataract surgery".Due to the exchange of a multifocal lens to a monofocal lens may have been 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 ; 8007579780
• MDR Report Key: 15518190
• Report Number: 1119421-2022-02095
• Device Sequence Number: 6055599
• Product Code: MFK
• UDI-Device Identifier: 00380652419901
• UDI-Public: 00380652419901
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 11/30/2024
• Device Model Number: TFAT50
• Device Catalogue Number: TFAT50.270
• Device Lot Number: 12763259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2019
• 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: AMVISC; BARRETT; MONARCH II IOL CARTRIDGE B; MONARCH III IOL INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female