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

Model Number	CCW0T5
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case in the lens carton.The lens was replaced into the lens case in a semi-folded position between the outside of the posts and the inner wall of the lens case.Viscoelastic was dried on the lens.Both haptics were folded onto the anterior optic surface, similar in appearance to a lens that has been loaded into a cartridge.The optic edge was pressed against a post of the lens case.The lens was cleaned with klrp for further evaluation.The reported scratch was not observed.The posterior optic surface has a cracked area of damage near the optic edge.The cracked damage may have been interpreted as a scratch by the customer.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were used.The product investigation could not identify a root cause for the reported complaint of lens was scratched, in and out.Upon removal of the dried viscoelastic, it was determined the reported scratch damage was not observed; however, one area of the optic was cracked.This damaged area may have been interpreted as the reported complaint.The haptics were folded onto the optic, as if loaded into a cartridge.New information was provided that the event may be "possibly due to loading error".The potential "loading error" was not specified.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 adequate viscoelastic was placed into the cartridge prior to loading the lens.The monarch 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.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.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
A nurse reported that during an intraocular lens (iol) implant procedure, lens was scratched after implantation.Lens was explanted in initial procedure.The procedure completed on the same day.According to the surgeon, the likely cause of the event was a possible loading error.There was no patient harm.

• Brand Name: CLAREON TORIC UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21421960
• Report Number: 1119421-2025-00455
• Device Sequence Number: 18040243
• Product Code: MJP
• UDI-Device Identifier: 00380652434027
• UDI-Public: (01)00380652434027(17)260507(11)220509(10)15409443
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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 Expiration Date: 05/07/2026
• Device Model Number: CCW0T5
• Device Lot Number: 15409443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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 OVD.
• Patient Age: 85 YR
• Patient Sex: Female