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

Model Number	CC60WF
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A surgeon reported that during an intraocular lens (iol) implant procedure, the iol was fine and each haptic had a normal bulb.The surgeon then noticed an extra bulb on the edge of the optic.The surgeon was able to easily remove the extra piece, and there were no issues.The original iol remained in the eye, and only the extra piece was removed.There was no patient harm.Additional information was received stating that, in the surgeon's opinion, a small remnant of the end of a haptic was present on the optic.Both haptics of the implanted lens was intact, and the surgeon considered that the remnant originated from another lens, which caused or contributed to the event.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.The reported product lot number was not provided.Lot specific reviews for similar complaints or non-conformances could not be conducted.However, before production release, each device history record is reviewed to ensure that the product met the required specifications and release criteria.A photo was provided.The photo showed an implanted single-piece lens.One haptic was visible folded over the optic.The second haptic was not pictured.Ther appeared to be a broken haptic tip on the anterior surface at the edge of the optic.No determination can be made from the photo.Root cause has not been identified.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 ; 8007579780
• MDR Report Key: 25185311
• Report Number: 1119421-2026-01057
• Device Sequence Number: 16141158
• Product Code: HQL
• UDI-Device Identifier: 00380652396837
• UDI-Public: (01)00380652396837(17)290708(11)250710(10)16069578
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: 16069578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 07/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM; GRISHAUER FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Age: 64 YR
• Patient Sex: Female