MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon IOL; Intraocular Lens

Model Number	SY60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported during intraocular lens (iol) implant procedure, the surgeon noticed optical part of iol had cracks after the iol was implanted into the eye.The lens was explanted during initial procedure.The procedure was completed on same day.There was no patient harm.Additional information received via regulatory agency stating that the iol appeared normal, with no abnormality observed by the naked eye.After implantation into the patient's eye, a distinct scratch was observed in the central area of the iol under the microscope and procedure was completed by using another unspecified lens.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 ; +1(800)757-9780
• MDR Report Key: 50945173
• Report Number: 9612169-2026-02240
• Device Sequence Number: 10348295
• Product Code: HQL
• UDI-Device Identifier: 00380652251518
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 25992061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 02/17/2025
• 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: CLAREON MONARCH IV IOL, Injector.; MONARCH III IOL, Cartridge D.; Unspecified viscoelastic.
• Patient Age: 71 YR
• Patient Sex: Male