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

Model Number	TFNT50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported that following implantation of an intraocular lens (iol) the patient experienced elliptical rings around lights, tail lights.Additional information was requested and received stating patient had lights upon lights, concentric rings within rings of different sizes.She gets glare off of all reflective surfaces.Additional information was requested and received stating lens was explanted in a secondary procedure with different lens.
Additional Manufacturer Narrative
The lens was returned submerged in liquid inside a plastic vial.The lens was removed from the liquid and allowed to air dry.The optic has light scratches that extend across the optic rings and the optic center.These scratches are observed on the anterior and posterior surfaces.A power and resolution test was conducted by an engineering technician.The optical resolution is acceptable; lens meets specification for focal length for a 17.0 diopter and cylinder 3.00 reading for a company model lens.Product history records were reviewed and documentation indicated the product met release criteria.The root cause cannot be determined for the reported complaint.The explanted lens was returned and evaluated.The optic has light scratches on the anterior and posterior surfaces.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria if present during the manufacturing process.A review of the manufacturing history record documentation indicates that the product met release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.It cannot be 100% confirmed if the damage was induced during delivery or during removal of the lens from the eye.A power and resolution test was conducted with the returned lens.The optical resolution is acceptable; lens meets specification for focal length for a 17.0 diopter and cylinder 3.00 reading for a company model lens.Information in the file indicated that the company (3.00 cyl.) 17.0 diopter (add power +2.2/+3.2) lens was removed and replaced with a non-company monofocal lens model of the same diopter.Due to the information that the multifocal toric lens model was replaced with a monofocal non toric lens model this may suggest that the event may not be related to the product, and that the replacement lens model was a better selection for the patient¿s vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 15752808
• Report Number: 1119421-2022-02385
• Device Sequence Number: 2958882
• Product Code: MFK
• UDI-Device Identifier: 00380652416528
• UDI-Public: 00380652416528
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: 09/30/2024
• Device Model Number: TFNT50
• Device Catalogue Number: TFNT50U170
• Device Lot Number: 12746876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female