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	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported during intraocular lens (iol) implant procedure, the surgeon noticed scratch after the iol was implanted into the eye.The lens was explanted during initial procedure.Additional information has been requested and received by stating, a foldable intraocular lens was placed from the package into the inserter.A 19.0 diopter company lens was placed in the capsular bag and rotated to 10 degrees.There was a scratch in the center of the lens.The ring was removed.The lens was removed, cut out of the eye.Iris hooks were placed and the lens was removed.The main wound was widened.A new company lens of same model and diopter was used and placed in the bag and no scratch was seen.The iris hooks were removed.Two 10.0 nylon sutures were used due to the main wound widening.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50195028
• Report Number: 1119421-2026-01671
• Device Sequence Number: 15924578
• Product Code: MJP
• UDI-Device Identifier: 00380652457361
• UDI-Public: (01)00380652457361(17)280806(11)240808(10)15902224
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.190
• Device Lot Number: 15902224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 08/08/2024
• 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
• Patient Sex: Unknown