MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon Toric IOL; Lens, Intraocular, Toric Optics

Model Number	CNW0T4
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that, during intraocular lens implantation surgery, the lenses had cracks upon being loaded & inserted into the eye.The cases were completed and there was no patient harm.Additional information has been requested and received stating that the first lens was implanted into the eye using the loader.Upon insertion, a crack was observed in the middle of the optic.Based on this observation, the surgeon decided to explant the lens during initial procedure.A second lens was then implanted using the loader; however, a very small non-central crack was noted, and the haptic was trailing.Additionally, the bulb on the haptic became caught in the inserter and twisted beneath the injector.Despite multiple attempts to release it, the distal portion of the haptic broke off.Consequently, this lens was also explanted during initial procedure.A third unspecified lens was subsequently implanted without any issues.The procedure was completed the same day.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 Toric 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: 50671190
• Report Number: 1119421-2026-01836
• Device Sequence Number: 21217283
• Product Code: MJP
• UDI-Device Identifier: 00380652410199
• UDI-Public: (01)00380652410199(17)300328(11)260330(10)16227908
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: CNW0T4
• Device Lot Number: 16227908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 03/30/2026
• 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 III IOL Delivery System, Cartridge D; MONARCH III IOL Delivery System, Injector; McPherson forceps; VISCOAT Ophthalmic ViscoSurgical Device
• Patient Age: 88 YR
• Patient Sex: Male