MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT30
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Blurred Vision (2137)
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 consumer reported that following an intraocular lens (iol) implant procedure, the patient had blurred vision from the time he/she left hospital.Consumer was told by physician from eye center that the implant moved and needed another surgery to correct it.Consumer had surgery and still had blurred vision.The doctor has not fixed the problem.Additional information has been requested, received and stated patient had blurred vision after first surgery and after second surgery for realignment.Extremely blurred in low light conditions, could not drive anymore at night.The patient had discussed with physician.Physician response was second surgery which did not correct problem.Now told consumer to get a contact lens with no prescription from optometrist which was not available.Also prescribed eye drops to make pupils smaller which the consumer has not gotten yet.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint of blurred vision.The product remains in the eye.Each lens is 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 consumer reported the complaint of blurred vision.A repositioning procedure occurred; however, the blurry vision continued.The patient reported that they have discussed with their doctor regarding the second surgery of repositioning.The patient reported that they were told to get a contact lens and was prescribed eye drops to make pupils smaller.Initial reporter gave company permission to contact surgeon.Due diligence has been performed in an attempt to obtain further information on this event.The facility has not responded to request for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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: 19482962
• Report Number: 1119421-2024-01085
• Device Sequence Number: 8029780
• Product Code: MFK
• UDI-Device Identifier: 00380652418683
• UDI-Public: (01)00380652418683(17)240731(11)190822(10)12736040(21)12736040048
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.190
• Device Lot Number: 12736040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 08/22/2019
• 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: Female