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

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	11/17/2022
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced wavy vision, poor vision, dissatisfaction and halos.The iol was exchanged for monofocal lens model 20 days following the initial implant procedure.Additional information has been received and stated that, there was no patient harm reported.The lens was replaced with non company monofocal iol.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens has been cut in two pieces, typical of insertion and removal from the eye.Cracks and scratches are observed on the optic.Marks are observed on both sides of the optic that are similar to those left by a surgical instrument used to grasp the lens.A power and resolution inspection could not be conducted due to extensive damage.Qualified associated products were indicated.The root cause for the reported events could not be determined.The file indicates multifocal company (1.50cyl), 21.0 diopter was replaced with an monofocal lens.Due to the exchange of a multifocal toric lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16112284
• Report Number: 1119421-2023-00053
• Device Sequence Number: 12224045
• Product Code: MJP
• UDI-Device Identifier: 00380652457408
• UDI-Public: 00380652457408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 01/05/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.210
• Device Lot Number: 15328824
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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: LOADING FORCEPS; MONARCH III CARTRIDGE D; MONARCH IV INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown