MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SA6AT8
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Headache (1880)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Event or Problem Description
A physician reported that a planned explant with patient reason headache.Clinical reason iol at 157° should be at 145° had t8 should be t7.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in a.2., a.3.A., b.2., b.5., b.6., b.7., d.6.A., d.10., h.3., h.6., and h.11.The product was not returned.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.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Rotation of the acrysof toric iol away from its intended axis can reduce the astigmatic correction.The information provided indicated the clinical reason was the iol was at 157° and it should be at 145°; patient has t8 should be t7.Information was provided that the sa6at8(5.25cyl), 12.5 diopter lens was replaced with a ccw0t7(4.50cyl), 12.5 diopter lens.This would indicate the replacement was an improved choice for the patient's visual needs.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
Additional information has been requested and received stating that the lens was explanted and replaced with a different model and diopter company lens.There was no further impact to the patient.According to the surgeons opinion, wrong iol power caused or contributed to the event.Operation power was determined by intraoperative ora results.

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE 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: 22873574
• Report Number: 1119421-2025-02308
• Device Sequence Number: 12184865
• Product Code: HQL
• UDI-Device Identifier: 00380652338264
• UDI-Public: (01)00380652338264(17)251025(11)201026(10)15109161
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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 Expiration Date: 10/25/2025
• Device Model Number: SA6AT8
• Device Lot Number: 15109161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 10/26/2020
• 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 II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; ORA SYSTEM 2000; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female