MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT315
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); Eye Irritation (4803)
Type of Reportable Event	Serious Injury
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 that, after intraocular lens implantation surgery, the patient experienced continued discomfort.Hence the lens was explanted and replaced with another lens in a secondary procedure.Additional information has been received stating that the lens was exchange due to the dislocation of the lens.
Additional Manufacturer Narrative
Corrected information provided in h.6.Correction: on initial mdr the product code should have been e0845 instead of e2401.Additional information was provided in b.5., d.9., h.3., h.6.And h.11.The lens was returned submerged in clear liquid inside a small glass container.The lens was removed and allowed to air dry prior to evaluation.The optic has been cut into three pieces, typical in appearance to an insertion and removal.Multiple small areas of starburst damage were observed in the lens material, typical of damage caused by a yttrium aluminum garnet (yag) laser procedure conducted post implantation.One optic portion has lines of cracked damage typical in appearance to an instrument used to grasp the lens.A power (sphere and cylinder) and optical resolution retest could not be conducted due to the lens damage.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations that could have contributed to this event were identified.All corresponding production release specifications defined in the device master record were met.Associated product information was not provided.The product investigation could not identify a root cause for the reported complaint.No information was given as to the cause of the dislocation.The lens was returned cut into three pieces, typical of an insertion and removal.Additional lens damage was observed.Each lens was subjected to a 100 percent assessment of the power (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power (sphere and cylinder) and resolution of the returned lens could not be re-evaluated due to the optic damage.Information indicated that intra ocular lens (iol) was inserted into the patient on (b)(6) 2021, but due to the patient's continued complaints of discomfort, it was exchanged on (b)(6) 2025.Additional information was provided that the company lens with (1.50cyl), 19.5 diopter (1.5 extended depth of focus) lens was replaced with a "third party" lens (model and diopter unknown).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that, on checking with the hospital about the patient's case, it was confirmed that yag laser procedure was performed before the lens explantation.

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION 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: 21900284
• Report Number: 1119421-2025-01175
• Device Sequence Number: 18321083
• Product Code: POE
• UDI-Device Identifier: 00380652421638
• UDI-Public: (01)00380652421638(17)260310(11)210312(10)15157773
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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: 03/10/2026
• Device Model Number: DFT315
• Device Catalogue Number: DFT315.195
• Device Lot Number: 15157773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown