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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
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 healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient was unable to adapt to daily life due to residual astigmatism and refractive error.The lens was exchanged 1 month following the initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned inside a small plastic cup with an opened foil package that has been taped close.Solution was dried on the lens.The optic was cut into pieces.One optic portion was cracked near the central optic zone.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.Product history records were reviewed and documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified associated products were used.The root cause cannot be determined for the reported complaint of "residual astigmatism and refractive error, explant'.The explanted lens was returned in pieces with additional damage.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 initial report description indicated the patient had maladaptation to the multifocal lens.Information was provided that the multifocal company 22.0 diopter (add power +2.2/+3.2 diopter) was removed and replaced with a non-company lens.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that the replacement lens was non company model.

• Brand Name: ACRYSOF IQ PANOPTIX 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: 19379821
• Report Number: 1119421-2024-00998
• Device Sequence Number: 7619892
• Product Code: MFK
• UDI-Device Identifier: 00380652357777
• UDI-Public: 00380652357777
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.220
• Device Lot Number: 15324943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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: I-FLEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown