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

Model Number	TFAT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient was not happy with the vision, clinical reason being residual astigmatism.The iol was explanted and exchanged for an unknown atiol following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
The explanted lens was returned sealed in a self-sealing non-company peel pouch.Solution and possibly blood was dried on the lens.The lens was cleaned with klrp (klotho-related protein klrp) for evaluation.No damage was observed to the lens.A dimensional (plan view) inspection was conducted.The lens was within the specification per the approved template.A power and resolution test was conducted on this lens by an engineering technician.The lens was evaluated for the power (spherical and cylinder) and the optical resolution.The lens met specification for a tfat30 (1.50 cyl) 11.5 diopter lens.Product history records were reviewed and documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The explanted lens was undamaged.Based on our evaluation of the returned product, and information provided on the completed questionnaire, the root cause for the reported event was unrelated to the lens.The root cause was indicated on the questionnaire to be due to residual astigmatism.The tfat30 (1.50 cyl) 11.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company lens 12.0 diopter.The form indicated that the replacement lens was an advanced technology lens.It is unknown if it contained a toric component.The information provided by the customer supports that the replacement lens was an improved selection for this patient¿s vision needs.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: 17288510
• Report Number: 1119421-2023-01232
• Device Sequence Number: 14837033
• Product Code: MFK
• UDI-Device Identifier: 00380652418539
• UDI-Public: 00380652418539
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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: 10/31/2024
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.115
• Device Lot Number: 12759818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2019
• 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: HEALON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown