MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET3
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.The lens was cleaned with klrp for further evaluation.The haptics were pliable when manipulated.No haptic issue observed.The optic had light scratches on the anterior and posterior sides of the lens.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.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.Qualified associated products were indicated.The reported scratch was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The lens was cleaned with klrp for further evaluation.The haptics were pliable when manipulated.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.The instruction for use (ifu) instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.Using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly, causing delivery issues and/or damage.Follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens (iol) to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.During lens loading and insertion, do not allow the company specific iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during the intraocular lens (iol) implantation procedure, the lens was scratched and would not unfold.Additional information was received stating that the issue noticed during loading.There was no patient contact.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION 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: 25427236
• Report Number: 1119421-2026-01229
• Device Sequence Number: 15999672
• Product Code: MJP
• UDI-Device Identifier: 00380652455268
• UDI-Public: (01)00380652455268(17)270530(11)230601(10)15646035
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: CCWET3
• Device Lot Number: 15646035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC VISCOSURGICAL DEVICE
• Patient Sex: Unknown