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 Code	Blurred Vision (2137)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry distance vision and also need readers more often than he would like.The iol was exchanged for another lens model following the initial implant procedure.Additional information was requested.
Additional Manufacturer Narrative
Additional information was added in h.3.,h.6.And h.11.The lens was returned for evaluation.Solution is dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.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.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.A power and resolution inspection could not be conducted due to extensive damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the multifocal 13.5 diopter (add power +2.2/+3.2) lens was replaced with a non-company multifocal lens with a 15.0 diopter.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19890587
• Report Number: 1119421-2024-01492
• Device Sequence Number: 7086230
• Product Code: MFK
• UDI-Device Identifier: 00380652413510
• UDI-Public: (01)00380652413510(17)270509(11)230511(10)15599392
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: CCWTT0
• Device Catalogue Number: CCWTT0.135
• Device Lot Number: 15599392
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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: AMVISC OVD; MONARCH CARTRIDGE; MONARCH INJECTOR; RPL LENS SBL3 SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male