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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2025
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).
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, explanted iol with reason unhappy with vision.Clinical reason for the explant was stated leading haptic was broken.The iol was replaced with unspecified lens approximately two months after initial procedure.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.It was indicated the original lens was implanted (b)(6) 2025; the broken haptic was noted (b)(6) 2025.No issues were reported at the time of implantation.The root cause for the reported broken haptic may be related to a failure to follow the ifu (instructions for use).The viscoelastic indicated is not qualified for the lens/company cartridge combination used.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.The root cause for the reported visual issue could not be determined.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company lens (1.50cyl), 18.0 diopter (add power +2.17/+3.25) lens was replaced with a non-toric company lens, 19.0 diopter (add power +217/+3.25) lens.Due to the exchange of a toric lens to a non-toric lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.Information indicated the patient still complained of vision issues after the exchange.A yag (yttrium aluminum garnet) was performed (b)(6) 2025.No additional complaints noted from the patient after the yag.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in 3.A., b.5., b.6.And d.10.Additional information was provided in h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating patient continues to complain vision is not great- yag was scheduled.There was no further impact to the patient.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22873294
• Report Number: 1119421-2025-02307
• Device Sequence Number: 12213113
• Product Code: MJP
• UDI-Device Identifier: 00380652457347
• UDI-Public: (01)00380652457347(17)280103(11)240105(10)15775888
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.180
• Device Lot Number: 15775888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/10/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/10/2025; 11/04/2025
• Date Device Manufactured: 01/05/2024
• 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: HEALON; MONARCH II FORCEPS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female