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

Model Number	CCWTT4
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	06/22/2023
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 had glares and halos.The iol was exchanged for another company lens.Clinical reason for explant mentioned as positive and negative dysphotopsia, residual astigmatism.There are two medical device reports associated with this patient.This report is associated with the left eye.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was added in d.9., d.10., h.3., h.6.And h.11.The lens was returned in a plastic specimen jar.Viscoelastic was dried on the lens.The optic was cut into two pieces, typical of an insertion and removal.The optic edge had a large broken area.The lens material of the broken optic area was not returned.The posterior optic surface was gouged between the optic center and the edge.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.Information was provided that indicated the use of a qualified cartridge and handpiece.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined.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.An intraocular lens (iol) exchange for a difference equal to or greater than two diopters indicates a calculation error may have occurred.The panoptix toric (2.25cyl), 22.5 diopter (add power +2.2/+3.2) was replaced with a non-company, non-toric, 16.0 diopter lens.Information was also provided that the patient has dry eye syndrome and fuchs.The combined information of patient pre-existing conditions and the replacement lens being non-toric, with a 6.5 diopter difference, may suggest that the complaint was unrelated to the initially implanted lens.File will be reopened if new information is received.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 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: 19926415
• Report Number: 1119421-2024-01532
• Device Sequence Number: 2761009
• Product Code: MJP
• UDI-Device Identifier: 00380652457965
• UDI-Public: (01)00380652457965(17)260215(11)220217(10)15354890
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 02/15/2026
• Device Model Number: CCWTT4
• Device Catalogue Number: CCWTT4.225
• Device Lot Number: 15354890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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: MONARCH II LOADING FORCEPS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; REPL LENS: LAL 16.0, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female