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

Model Number	DFT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that after an intraocular lens (iol) implantation procedure, consumer experienced blurriness, it¿s like a film over eye.Additional information was received from the consumer stating the vision remains unclear.The left eye, which still has a cataract, provides better clarity compared to the right eye, which was out of focus.Despite waiting for a few months to see if the condition would improve, there was no noticeable change.The ophthalmologist referred consumer to a specialist in lens replacement and was scheduled for lens replacement.Although the consumer has some glasses, it wasn't very helpful, as the optometrist cannot make further corrections.
Additional Manufacturer Narrative
Additional information was added in h.3.,h.6.And h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating the lens was explanted and replaced with non-company lens.
Additional Manufacturer Narrative
Correction information was provided in d.4.Product udi has been updated.Additional information was provided in b.2., b.5., and h.6.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 20156908
• Report Number: 1119421-2024-01750
• Device Sequence Number: 11821453
• Product Code: POE
• UDI-Device Identifier: 00380652421201
• UDI-Public: (01)00380652421201(17)260509(11)210511(10)15201217(21)15201217009
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2026
• Device Model Number: DFT015
• Device Lot Number: 15201217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/11/2024
• Date Device Manufactured: 05/11/2021
• 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: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown