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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned between a sheet of adhesive plastic.One haptic is broken-gusset area, not returned.The optic is cut from the edge across the center.The lens was cleaned with klotho-related protein (klrp) to remove from the adhesive.A short narrow scratch was observed on the posterior surface.The scratch was at an angle to the fold path.A small gouge was observed on the anterior surface.The used company cartridge was returned.Viscoelastic was observed in the cartridge.The nozzle was cracked on the top, which split as it entered the thinner tip.The tip had heavy stress.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Complaint and product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated with a non-qualified viscoelastic.The root cause for the damage lens may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was indicated.It was stated the lens was kept warm.Lenses should be at room temperature.How the lens was warmed and to what temperature was not provided.The returned lens was damaged.The reported crack was not observed.The lens was cut across the center typical of a removal.A scratch was observed which was angled to the fold path.A small gouge was also observed on the anterior surface.This damage may have been caused by an instrument used to grasp the lens.The returned cartridge was also damaged.The nozzle was cracked on the top, which split as it entered the thinner tip.This type of damage is typically progressive and worsens as the lens is advanced.The damage on the top of the nozzle started in the thick wall cone 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 typically occurs if the lens is not positioned correctly for advancement and/or if there is a lack of viscoelastic between the lens and the nozzle lumen.The 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.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 half turn to engage the threads and then stop.The intra ocular lens (iol) will now be in the dwell position.Inspect to ensure the plunger is behind the optic.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.
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implant procedure, the lens was defective and cracked.The crack was in center of the optic.The lens was implanted & explanted.The lens was kept warm, loaded with the company forceps and only folded in cartridge for delivery then loaded immediately before handing using room temp non-company viscoelastic.Additional information has been requested.There are two medical device reports associated with this report.This is 2 of 2.

• 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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21457456
• Report Number: 1119421-2025-00513
• Device Sequence Number: 15432025
• Product Code: POE
• UDI-Device Identifier: 00380652405782
• UDI-Public: (01)00380652405782(17)280304(11)240306(10)15815421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/25/2025

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 Catalogue Number: CCWET0.205
• Device Lot Number: 15815421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; VISCOELASTIC USED: AMVISC
• Patient Sex: Unknown