MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CCWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Type of Reportable Event	Serious Injury
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported following the intraocular lens implantation the patient had experienced halos, distance vision was blurry and was out of focus.The lens was explanted in a secondary procedure and replaced with another lens.Additional information has been requested and received stating there was no harm to the patient.The patient issues have resolved and the prognosis was good.
Additional Manufacturer Narrative
The lens was returned on a triangular piece of medical sponge inside a plastic bag.Solution was dried on the lens.The optic was cut into two pieces.Each optic portion contained a full, undamaged haptic.The optic anterior surface had small cracked areas and scratches near the center.Information was provided that indicated the use of a qualified cartridge.A non-qualified handpiece and a non-qualified viscoelastic were indicated.The root cause cannot be determined for the reported complaint.The explanted lens was returned in pieces, typical of damage created to remove a lens from the eye.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 returned lens was scratched and cracked.A failure to follow the instructions for use (ifu) also occurred.A non-qualified handpiece and viscoelastic was indicated.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company recommends using the qualified company iol delivery system or any other company qualified combination.The company lens was removed and replaced with a non-company lens.(the reported replacement lens model ending letter is a possible typographical error because that is an invalid model; however dxxroov is a valid model.Therefore, it is logical that the replacement lens was a dxxroov lens model.) the exchange of the non-toric lens to a non-company lens that is one half diopter higher in power may suggest that the replacement lens was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 16681245
• Report Number: 1119421-2023-00589
• Device Sequence Number: 15277201
• Product Code: MFK
• UDI-Device Identifier: 00380652413725
• UDI-Public: 00380652413725
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 12/12/2024
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.240
• Device Lot Number: 15236938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 04/27/2023
• Date Device Manufactured: 07/21/2021
• 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: DXXR00U 24.5.; MONARCH III IOL CARTRIDGE C.; MONARCH III IOL INJECTOR.; OCCUCOAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown