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

Model Number	CCWET0
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
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 during an intraocular lens (iol) implant procedure, the lens was scratched going into cartridge.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
Additional information was provided in a.2; a.3a; a.3b; a.4; b.5; d.10; e.1., h.3., h.6.And h.11.The lens was returned in the nozzle entry area of a company cartridge in the lens carton, along with the disassembled lens case.An inadequate amount of viscoelastic was observed dried in the cartridge.Both haptics were tucked into the optic fold on the anterior optic surface.The posterior of the nozzle was cracked beginning in the thick wall cone area and extending into the cartridge tip.The cartridge tip also had light to heavy stress.The cartridge had evidence of placement into a handpiece.The location of the lens in the nozzle entry area may have been the result of retracting a manual handpiece from the cartridge for return shipment of the sample.The cartridge was cleaned for further evaluation.The lens was removed during cleaning.A linear scratch was observed on the optic posterior surface, just left of center, similar to a mispositioned lens during a plunger underride.Topcoat dye stain testing was conducted with acceptable results.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.A non-qualified viscoelastic was used.The reported scratch was observed on the posterior of the optic, traveling just left of center, similar in appearance to damage during a plunger underride.The root cause for the reported complaint was most likely related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used and an inadequate amount of viscoelastic was used.The ifu instructs: company foldable iols are qualified for use with a c ompany qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs to completely fill the cartridge with 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.Based on the observed nozzle and tip damage to the returned cartridge, a handpiece has been advanced through the cartridge to the tip exit.The returned company cartridge nozzle was cracked on the posterior.The damage started in the thick wall cone area and extended into the thinner tip area.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.Damage in the thick cone wall section has been associated with the use of cold viscoelastic.The ifu instructs to use viscoelastic, which has been allowed to come to the operating room temperature.This type of damage may also occur if the lens/plunger are not positioned correctly for advancement.The ifu instructs: 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.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The intraocular lens (iol) will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company 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
Additional information was requested; there was no patient contact and the procedure was completed on the same day.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 23757337
• Report Number: 1119421-2025-03108
• Device Sequence Number: 10345569
• Product Code: POE
• UDI-Device Identifier: 00380652405836
• UDI-Public: (01)00380652405836(17)290416(11)250418(10)16031370
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 01/30/2026

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: CCWET0
• Device Lot Number: 16031370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 04/18/2025
• 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: ENDOCOAT; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNKNOWN LOADING/FOLDING FORCEPS; UNSPECIFIED CARTRIDGE; UNSPECIFIED INJECTOR/HANDPIECE
• Patient Sex: Unknown