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	Blurred Vision (2137)
Date of Event	04/05/2024
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.Lens appeared to have settled down, but he did not have any functional near or intermediate vision.Although, distance appeared fine.He had no other eye problems.He stated, his appointment with his surgeon has been scheduled, where surgeon would suggest some adjustments for the second eye.Additional information has been requested.Received and stated, the patient occasionally wears soft contact lenses, but not within a week of measurement.He was reluctant to have the iol implanted in other eye, until there is no establishment why the first has no functional reading or intermediate vision.The consumer met with his eye surgeon for an update, concerning lack of functional reading and intermediate vision.The consumer was unwilling to go ahead with surgery on his other eye, before it is established, why the first surgery did not result in the anticipated benefits.He has been experiencing considerable difficulty with one functional eye.
Additional Manufacturer Narrative
Correction information was provided in d.4.Additional information provided in h.3., h.6.And h.11.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated with a non-qualified viscoelastic.This would not be applicable to the reported complaint.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.File will be reopened if new information or the sample is received.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: 19739951
• Report Number: 1119421-2024-01320
• Device Sequence Number: 3702885
• Product Code: POE
• UDI-Device Identifier: 00380652421133
• UDI-Public: (01)00380652421133(17)280710(11)230713(10)15679577(21)15679577069
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Model Number: DFT015
• Device Lot Number: 15679577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/23/2024
• Date Device Manufactured: 07/13/2023
• 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: HEALON PRO.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male