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

Model Number	CNW0T3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, it was noted that the lens had an unspecified issue.Additional information has been requested, received and stated the lens was loaded into company cartridge then placed in an inserter, it was then injected into the eye and a scratch was noticed on the lens.How the scratch got their reporter did not have an answer for.Lens was then removed and replaced with a new unspecified lens during initial procedure.There was no patient harm.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens is split and cracked in multiple areas.The lens is cut in half, typical of insertion and removal from the eye.One portion of the optic with a haptic was not returned.The returned portion of the lens was pressed against and between three posts in the lens case.Two parts of the optic are broken off where it is pressed against the posts.A small piece of lens material that is broken off is adhered to the optic by solution.Marks are observed on both sides of the optic that are similar to those left by a surgical instrument used to grasp the lens.All product and batch history records are quality reviewed prior to product release.The file indicates the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.Lens damage was observed.The observed cracks could be interpreted as the reported scratch.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).The file indicates the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.The viscoelastic indicated is not qualified for the lens/company combination used.Company foldable iols (intraocular lens) are qualified for use with a company 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: 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.Company ifu: 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: 2025-10051 h.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 21675978
• Report Number: 1119421-2025-00793
• Device Sequence Number: 8311432
• Product Code: MJP
• UDI-Device Identifier: 00380652409575
• UDI-Public: (01)00380652409575(17)270711(11)230713(10)15675512
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/24/2025

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: CNW0T3
• Device Lot Number: 15675512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: HEALON OVD USED; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Patient Age: 76 YR
• Patient Sex: Male