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

Model Number	CC60WF
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.A device history 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 device master record were met.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during the intraocular lens (iol) implant procedure, a very small foreign body was found within the lens, exhibiting a metallic sheen near the haptic, approximately the size of a toric marking.The finding was noted immediately after implantation, and he attempted to polish it without success.The foreign body did not appear metallic.Additional information received and stated that the patient had a normal postoperative course.After inserting the lens, it was noted that there was a square-shaped refractive opacity that appeared to be within the lens adjacent to the optic.To ensure that the opacity was not on the surface, the surgeon used a soft-tip irrigation and aspiration handpiece over the area on both the front and back of the lens, without any movement of the opacity.The surgeon then used a hook and dragged it across the opacity several times, and it glided smoothly across the area as it would over the rest of the lens.This led to the belief that the opacity was within the lens itself.The surgeon did not want to remove the lens if the opacity was not causing harm.The surgeon discussed this with the patient and left the lens in the eye, with a plan to dilate the following day and examine it using the highest-powered slit lamp.At the slit lamp the next day, the opacity appeared clear and polychromatic.It did not appear like metal and again appeared to be within the lens itself.The surgeon planned to bring the patient back to take a non-magnified picture as requested.The patient was seeing very well and had no interest in lens removal as long as it was safe to remain in the eye.The lens was placed in the cartridge approximately 15 seconds before implantation.There was no impact to the patient.Visual acuity was 20/20, and healing was normal.

• 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 ; 8007579780
• MDR Report Key: 25351131
• Report Number: 1119421-2026-01174
• Device Sequence Number: 16063558
• Product Code: HQL
• UDI-Device Identifier: 00380652396820
• UDI-Public: (01)00380652396820(17)291025(11)251027(10)16136155
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 07/03/2026

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: 16136155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 07/03/2026
• Date Device Manufactured: 10/27/2025
• 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 Age: 81 YR
• Patient Sex: Male