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 Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.Clinical reason for explant mentioned as refractive error.The iol was explanted and exchanged with non company lens following the secondary implant procedure.Additional information received, patient had halos and glare and reported with no patient harm.
Additional Manufacturer Narrative
Additional information has been provided in d.4., h.3., h.6., and h.11 the lens was returned wrapped in folded, white gauze material.Viscoelastic was dried on the lens.The optic appeared cut into pieces, typical of a removal from the eye.The optic edges of both optic portions contained multiple areas that were split and cracked on the anterior and posterior surfaces.The damage travelled toward center of optic.Splintering cracked damage was also observed at the line of cut damage.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a qualified cartridge, handpiece, and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The completed questionnaire indicated that the event was glare and halos due to mutifocal iol (intraocular lens) in patient post lasik (laser -assisted in situ keratomileusis).The multifocal toric lens (1.50 cyl.) 19.5 diopter (add power +2.2/+3.2 diopter) was removed and replaced with a non-company monofocal toric 20.0 diopter lens.This information that the multifocal toric lens was replaced with a monofocal toric lens, one half diopter larger, may suggest that the monofocal replacement lens was an improved selection for this patient's vision needs.File will be reopened if new information is received.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: 19870066
• Report Number: 1119421-2024-01462
• Device Sequence Number: 15229803
• Product Code: MFK
• UDI-Device Identifier: 00380652418690
• UDI-Public: (01)00380652418690(17)260417(11)210419(10)15182231
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 04/17/2026
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.195
• Device Lot Number: 15182231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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: J&J MODEL DIU150, POWER 20.0, SN (B)(6); MONARCH II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male