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	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient had refractive error.The iol was exchanged for unspecified lens.Additional information has been requested, received and stated in the surgeon¿s opinion, halos and blurry vision caused or contributed to the event.The lens was exchanged with non-company lens.There was no further impact to the patient.There are two medical device reports associated with this patient.This report is associated with the right eye.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The lens was returned inside a small, plastic specimen cup.Viscoelastic was dried on the lens.The optic was cut into two pieces, typical of an insertion and removal.The lens was cleaned with klrp for further evaluation.One haptic was nicked on the distal anterior edge.The optic was cracked and split near the cut line in the center.Two separate areas of cracked damage in the shape of instruments used to grasp the lens were observed on the anterior optic surface and directly below on the posterior optic surface beginning at the optic edge.The other optic portion was torn, split, and cracked beside the cut line of damage on the posterior optic surface.This optic portion has one area of cracked damage in the shape of an instrument used to grasp the lens on the anterior optic surface and directly below on the posterior optic surface beginning at the optic edge.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 associated product information was not provided.The questionnaire indicated "not applicable" and "unknown" regarding the associated products used with this lens.It is unknown if qualified associated products were used.The product investigation cannot determine the root cause for the reported vision complaint.The lens was cut into pieces, typical of an insertion and removal.Additional lens damage was observed.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 (sphere and cylinder) and resolution of the returned lens could not be re-evaluated due to the optic damage.The multifocal company 2.25 cyl.17.0 diopter lens was removed and replaced with a non-company, 17.5 diopter lens.Due to the exchange of the multifocal lens 17.0 for an unknown lens one half diopter less in power, this may suggest that the replacement lens model with a lower diopter was an improved selection for this patient¿s vision needs.Information was provided that the patient had pre-existing ocular condition of glaucoma and no prior refractive surgeries.The physician's prognosis for the patient was stated as "good".No further information has been provided.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; 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: 25031179
• Report Number: 1119421-2026-00920
• Device Sequence Number: 8992200
• Product Code: MJP
• UDI-Device Identifier: 00380652457859
• UDI-Public: (01)00380652457859(17)260214(11)220216(10)15354900
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: 02/14/2026
• Device Model Number: CCWTT4
• Device Catalogue Number: CCWTT4.170
• Device Lot Number: 15354900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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: UNKNOWN FORCEPS.; UNKNOWN HANDPIECE.; UNKNOWN VISCOELASTIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male