MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced as poor vision and clinical reason for explant being mechanical breakdown.The iol was explanted and exchanged for a same model and same diopter company intraocular lens following the initial implant procedure.There was no further impact to the patient.Surgeons' prognosis was stated as good.Symptoms were resolved.Additional information received stating that the original lens rotated less than 20 degrees causing residual astigmatism.Lens was repositioned, it didnot stay and later explanted.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The lens was returned wrapped in white gauze material that was taped together and placed in a small brown envelope.The lens was broken (or cut) into multiple pieces.One haptic was cut in the haptic/optic junction (returned).The other haptic was not returned.Only three optic portions were returned.The portion of optic that would have included the other haptic was not returned in order to evaluate if the haptic was whole or broken.The three optic portions each had additional damage.The smallest optic portion has an anterior scratch and a chip on the anterior optic edge.The medium size optic portion was cut in a jagged pattern and has five torn and split areas of damage.The largest optic portion was broken on the edge near the haptic/optic junction.This portion had chunks of lens material broken (not returned) and several split and cracked areas of 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 non-qualified company cartridge was used.The diopter of this lens model is beyond the qualified range approved for use in the company cartridge.The diopter of this lens model (26.0) has been qualified for use in the company cartridge (25.5 to 30.0).A non-qualified company handpiece was used.A viscoelastic was used that is qualified for this lens when used with qualified associated products.The product investigation could not determine the root cause for the reported poor vision complaint.The explanted lens was returned broken (or cut) into multiple pieces, typical of damage to remove a lens from the eye.Each portion had additional damage.One haptic was cut and returned.The other haptic was broken and not returned.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 cnw0t4 (2.25 cyl.) 26.0 diopter lens was removed and replaced with a cnw0t4 (2.25 cyl.) 26.0 diopter lens.There was no change in the model, cylinder, or diopter for the replacement lens selection.The customer indicated that the original lens rotated less than 20 degrees causing residual astigmatism.The reason for the rotation was not provided.It cannot be verified that the original lens was at the intended axis.Rotation of the acrysof iq vivity¿ toric iol away from its intended axis can reduce the astigmatic correction.Misalignment greater than 30° may increase postoperative refractive cylinder.If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.The original lens was implanted in april, 2025 and explanted in september 2025.Further follow up from the site indicated that it was believed the lens had been repositioned but it didn¿t stay.So, then it was replaced.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 24127298
• Report Number: 1119421-2026-00157
• Device Sequence Number: 16049232
• Product Code: MJP
• UDI-Device Identifier: 00380652410274
• UDI-Public: (01)00380652410274(17)270812(11)230814(10)15695781
• 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: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: CNW0T4
• Device Lot Number: 15695781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male