MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported with a description of failure placement, implant stuck to the cartridge.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.Both haptics were bent in the gusset area.One haptic was broken in the distal area (returned).The optic was pressed against the posts and down into the well area of the lens case.No cartridge returned for evaluation.Product history records were reviewed and the documentation indicated the product met release criteria.Upon return, the lens was observed to be placed into the lens case incorrectly resulting in damage.The reported complaint could not be confirmed because the lens was not returned in a cartridge as described.The cartridge was not returned for evaluation.Not enough information was provided to determine if qualified associated products were used.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.Company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The instructions for use (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.Lens damage was observed that may have occurred due to how the lens was positioned in the lens case for return.All lenses are 100percentage inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.2., b.5.And h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.No further reports required.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information has been received and stated that the implant remained stuck to the side of the cartridge before being injected into the patient's eye.

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: 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: 21548883
• Report Number: 1119421-2025-00628
• Device Sequence Number: 11867136
• Product Code: HQL
• UDI-Device Identifier: 00380652251587
• UDI-Public: (01)00380652251587(17)280224(11)240226(10)15810359
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.250
• Device Lot Number: 15810359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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
• Patient Sex: Unknown