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 Code	Visual Impairment (2138)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
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 healthcare professional reported that, after intraocular lens (iol) implantation surgery, the patient experienced astigmatism over two diopter.The surgeon reported that, in the left eye the lens was currently 15 degrees but according to the calculation it should be 155 degrees.Unfortunately it was very twisted and the remaining astigmatism could come out from that.Additional information has been requested.
Event or Problem Description
A questionnaire was received.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.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.Information was provided that for the left eye, the lens is currently at 15 degrees; according to the calculation, it should be optimally at 155 degrees.Per the instructions for use (ifu): rotation of the company lens 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 hcp indicated there are no plans to explant at this time.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction: correction information was provided in h.6.On previous supplemental report smdr1 the eval method code b17 was an error.It should have been b20 on the smdr1.Additional information was provided in b.5.The manufacturer internal reference number is: (b)(6).
Event or Problem Description
Additional information received and stated that, the patient was not impaired as a results of the event.In the surgeon's opinion, distortion of the lens was the contributed cause of the event.

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18518457
• Report Number: 1119421-2024-00113
• Device Sequence Number: 6732358
• Product Code: POE
• UDI-Device Identifier: 00380652421515
• UDI-Public: 00380652421515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2024

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: DFT315
• Device Lot Number: 15687844
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 02/13/2024; 04/02/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/11/2024; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female