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

Model Number	SN6AT8
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A healthcare professional reported during intraocular lens (iol) implant procedure, the surgeon noticed that the lens was stuck inside the cartridge.Surgeon has attempted twice.The lens did not come out easily hence surgeon decided not to use force to avoid complication.Alternative lens has been used.The procedure was completed on same day without any harm or complication to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Corrected information provided in h.6.Correction: on initial mdr the product code instead of c21 it should be c20.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.3., d.9., d.10., h.3., h.6.And h.11.The lens was returned in in the lens case.Viscoelastic was dried on the lens.The lens was cleaned with klrp for further evaluation.A small crack was observed at one gusset area.A small chip was observed on the optic edge.The lens dimensions (plan view) were acceptable using an approved template.The used company iii (c) cartridge was also returned.Inadequate viscoelastic was observed in the cartridge.No damage was observed.The cartridge had evidence of placement into a handpiece.The used company iii (c) cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.Qualified associated products were indicated.The reported "stuck in cartridge" could not be verified.The lens was returned in the lens case.The lens dimensions (plan view) were acceptable using an approved template.The root cause for the reported issue may be related to a failure to follow the instructions for use (ifu).Inadequate viscoelastic was observed in the returned cartridge.No problem was found with the returned cartridge.Topcoat dye stain testing was conducted with acceptable results.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC 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: 20917273
• Report Number: 1119421-2024-02475
• Device Sequence Number: 5108003
• Product Code: MJP
• UDI-Device Identifier: 00380652277587
• UDI-Public: (01)00380652277587(17)280924(11)230927(10)15723846
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2025

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: SN6AT8
• Device Catalogue Number: SN6AT8.235
• Device Lot Number: 15723846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 02/19/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/03/2025; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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 DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED HAND PIECE 8065977778
• Patient Sex: Unknown