MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T5
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2026
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 nurse reported that during the intraocular lens (iol) implantation surgery, the lens was scratched after implanting it.There was patient contact.The procedure was completed on the same day.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution and blood were dried on the lens.The lens had been cut in half, typical of removal from the eye.The lens was cleaned with klrp.A narrow scratch was observed on the posterior surface of the optic near one gusset area.The optic was chipped on the edge with multiple scraped areas midway on the optic.This damage was perpendicular to the travel path.This damage may indicate a plunger override occurred.A used company cartridge was also returned.Inadequate viscoelastic was observed in the cartridge.The cartridge nozzle was cracked on the left side.The crack split as it entered the thinner tip.Heavy stress was also observed.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.A qualified cartridge and handpiece were indicated.It is unknown if a qualified viscoelastic was used.The lens damage was observed.The damage appears to be related to a failure to follow the instructions for use (ifu).The optic was chipped on the edge with multiple scraped areas midway on the optic.This damage was perpendicular to the travel path.This damage may indicate a plunger override occurred.Inadequate viscoelastic was observed in the cartridge.The cartridge nozzle was cracked on the left side.The crack split as it entered the thinner tip.Heavy stress was also observed.This damage would indicate the lens and plunger were not in an acceptable position for advancement.Inadequate viscoelastic was observed in the cartridge.Company cartridge top coat dye stain testing was conducted with acceptable results.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.It is unknown if a qualified viscoelastic was used.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.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 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).

• 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 ; 8007579780
• MDR Report Key: 24895837
• Report Number: 1119421-2026-00791
• Device Sequence Number: 21150144
• Product Code: MJP
• UDI-Device Identifier: 00380652410656
• UDI-Public: (01)00380652410656(17)270703(11)230705(10)15671609
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 05/27/2026

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: CNW0T5
• Device Lot Number: 15671609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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 III CARTRIDGE D; MONARCH III INJECTOR
• Patient Age: 83 YR
• Patient Sex: Male