MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon Aspheric UV Absorbing IOL; Intraocular Lens

Model Number	CC60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implantation procedure, a lens was kept in a patient and was discovered to have a crack once it was sewn in.The iol was subsequently removed and replaced with another unspecified lens during the initial implantation procedure and the procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was not returned for analysis.Only the empty lens case was returned in the carton.There is no damage observed to the lens case or the locking arm mechanism.The lens case functions as intended.A batch record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the medical device file were met.Associated products were not provided.It is unknown if qualified products were used.The root cause could not be determined for the reported complaint.The intraocular lens (iol) was not returned for an evaluation.Associated products were not provided.It is unknown if qualified products were used.Company foldable intraocular lenses (iols) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The instructions for use (ifu) instructs that an 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 halfway 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 instructions for use 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 investigation has been completed based on current information.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaints are reviewed and monitored for adverse trends on a monthly basis.No adverse trends have been observed associated with the reported product and event.No further action has been identified for this reported event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action is warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: Clareon Aspheric UV Absorbing 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 ; +1(800)757-9780
• MDR Report Key: 50853743
• Report Number: 1119421-2026-01924
• Device Sequence Number: 10053624
• Product Code: HQL
• UDI-Device Identifier: 00380652396899
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: CC60WF
• Device Lot Number: 16291161
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 06/29/2026
• 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