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

Model Number	SY60WF
Medical Device Problem Codes	Inaccurate Delivery (2339); Device Dislodged or Dislocated (2923); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A pharmacist reported that during a left eye intraocular lens (iol) implant procedure, a placement failure occurred.The implant got stuck during deployment in the incision.The surgeon had to remove it with pliers during initial procedure, but the optic was marked.Then the surgeon decided to use a back-up lens to avoid optical defects linked to the marks on the implant.It was reported that this was due to mishandling of the device.The procedure was completed on the same day.Additional information has been requested.
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 ASPHERIC HYDROPHOBIC ACRYLIC 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: 22562483
• Report Number: 1119421-2025-02000
• Device Sequence Number: 19838901
• Product Code: HQL
• UDI-Device Identifier: 00380652251471
• UDI-Public: (01)00380652251471(17)280409(11)240411(10)15837765
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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 Catalogue Number: SY60WF.195
• Device Lot Number: 15837765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 04/11/2024
• 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: PLIERS; UNSPECIFIED REPLACEMENT BACK-UP LENS
• Patient Age: 69 YR
• Patient Sex: Female