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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is broken along with a piece of optic and returned in the lens case.A deep groove is observed on the anterior surface in the gusset area.The opposite haptic is bent from the gusset area pressed against a post in the lens case.The optic is pressed against and between three posts in the lens case.The optic is broken where it is against two posts.Cracks are observed near the area it is broken.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The lens was returned in the lens case and the cartridge was not returned.Qualified associated products were indicated.The ifu (instructions for use) instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ophthalmic viscosurgical device (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 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.Information was provided that the doctor went to place the lens in capsule, had a little resistance, but inserted.The back haptic didn't fully insert.There was an m-ring in place and couldn't get the lens fully inserted.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during the intraocular lens (iol) implant procedure, surgeon had trouble inserting the lens.There was patient contact.Additional information has been received that when placing the lens in capsule surgeon had a little resistance, but inserted.The back haptic didn't fully insert.The surgery completed same day with same model and diopter company lens.There was no patient harm.

• 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: 22293076
• Report Number: 1119421-2025-01706
• Device Sequence Number: 18365985
• Product Code: HQL
• UDI-Device Identifier: 00380652251549
• UDI-Public: (01)00380652251549(17)281103(11)241105(10)15939694
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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: SY60WF
• Device Catalogue Number: SY60WF.230
• Device Lot Number: 15939694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown