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

Model Number	SY60WF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned wrapped in white gauze material placed into a small brown envelope that was taped closed.The lens was removed from the gauze.Solution was dried on the lens.The optic was cut into two portions, typical of an insertion and removal.The lens was cleaned with klrp to further evaluate.One optic portion was scratched across the anterior surface.A small, cracked area was observed on the posterior surface.The optic has cracked damage beginning at the optic edge in the shape of an instrument used to grasp the lens.The damage was observed on both the anterior and directly opposite on the posterior surface.The other optic portion has cracked damage beginning at the optic edge in the shape of an instrument used to grasp the lens.The damage was observed on both the anterior and directly opposite on the posterior surface.The posterior optic surface has two small, cracked areas of damage between the center and the optic edge.The posterior optic surface was also scratched near the center.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.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.A qualified cartridge and viscoelastic were used with a company handpiece.The root cause cannot be determined for the reported complaint of iol tilting (initial described as mechanical breakdown).The root cause for the blurry vision was most likely unrelated to the product.An iol exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Based on the information provided, the blurry vision event does not appear to be related to the product.The company 18.0 diopter lens was exchanged for a company same model 21.0 diopter lens.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported that after an intraocular lens (iol) implantation surgery, the patient experienced blurry vision and the lens was tilting.Hence the lens was explanted and replaced with same model different diopter company lens in a secondary procedure.The clinical reason for explant was mentioned as mechanical breakdown.Additional information has been requested, received and stated there was no further patient impact.

• 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: 25199465
• Report Number: 1119421-2026-01064
• Device Sequence Number: 13007340
• Product Code: HQL
• UDI-Device Identifier: 00380652251440
• UDI-Public: (01)00380652251440(17)280506(11)240508(10)15847287
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.180
• Device Lot Number: 15847287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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 DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE..
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female