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

Model Number	SY60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A surgeon reported during intraocular lens (iol) implant procedure, upon implanting the lens into the eye, the trailing haptic was noted to be completely severed.The rest of the haptic was later found on the lens inserting forceps.The lens was explanted and replaced with new unspecified lens during initial procedure.The patient had dementia, narrow angles with shallow ac (anterior chamber), hazy cornea, and was moving significantly during surgery.The patient could not stay still for explantation so after much difficulty ended up having to convert to general anesthesia in order to complete the case.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.Solution and blood are dried on the lens.One haptic is broken in the gusset area (not returned).The lens is cut in half, typical of insertion and removal from the eye.A deep scratch is observed on the anterior surface of the optic.Product history records were reviewed, and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.Broken haptic damage was observed.All lenses are 100 percentage inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company's release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Information was provided that the broken portion of the haptic was later found on the lens inserting forceps.Associated products were not provided.It is unknown if qualified products were used.Company foldable iols (intraocular lenses) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu (instructions for use) 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.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).

• 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: 21695120
• Report Number: 1119421-2025-00833
• Device Sequence Number: 12974260
• Product Code: HQL
• UDI-Device Identifier: 00380652251617
• UDI-Public: (01)00380652251617(17)270620(11)230622(10)15671064
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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.265
• Device Lot Number: 15671064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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: UNSPECIFIED LENS INSERTING FORCEPS
• Patient Sex: Unknown