MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implantation procedure, after the lens was inserted into the patient¿s eye, one haptic was found to be broken.The lens remained implanted, and the detached haptic fragment was removed.The upper portion of the haptic remained attached to the optic.The remaining haptic stump unfolded.The remaining haptic was still of sufficient length, and the optic was well centered.The patient did not experience any adverse clinical consequences.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24470189
• Report Number: 9612169-2026-00450
• Device Sequence Number: 9581267
• Product Code: HQL
• UDI-Device Identifier: 00380652251587
• UDI-Public: (01)00380652251587(17)281208(11)241210(10)25964652
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: SY60WF
• Device Lot Number: 25964652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/29/2026
• Date Device Manufactured: 12/10/2024
• 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, CARTRIDGE D.; MONARCH III IOL, INJECTOR.
• Patient Sex: Unknown