MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Retinal Tear (2050); Visual Impairment (2138); Posterior Capsule Opacification (4807)
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 non-healthcare professional reported that after an intraocular lens (iol) implant procedure, a visiting surgeon from the kaluga branch performed phacoemulsification and implantation of an intraocular lens.After the surgery, complications began.The diagnostic and treatment department was closed, so the scheduled postoperative examination did not take place.After consulting ophthalmologists, the patient was unable to explain which lens had been implanted.The doctors stated that the discharge summary must indicate which lens was used, the method of implantation, and must include a sticker and an identification card from the package.The clinic sent the iol name and serial number by email, but no documents, photos, or stickers confirming the origin of the iol were provided.Anterior segment tomography revealed the cause of the visual deterioration, an 8.1-degree tilt relative to the horizontal plane of the eye.There was a gap with the posterior part of the capsular bag cavity and progression of secondary cataract in the operated left eye.The patient experienced tearing and foreign body sensation, a torn foveal macular, and rotation of the optic and the entire lens by 35 degrees clockwise.The healthcare professional had not confirmed that the event met criteria of reportability.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
Corrected information provided in h.6., in the initial mdr, the imdrf health impact code was reported as f1904; upon review, the appropriate code was determined to be f24.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24172929
• Report Number: 9612169-2026-00181
• Device Sequence Number: 15845349
• Product Code: MFK
• UDI-Device Identifier: 00380652408165
• UDI-Public: (01)00380652408165(17)281012(11)241014(10)25926976
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.220
• Device Lot Number: 25926976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 10/14/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown