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 Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
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.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.Information was provided that the company (b)(6) lens was replaced with another company (b)(6) lens.Patient is now happy now with the final results.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, the patient had visual acuity of 20/50 vision.Also had astigmatism and double-vision.The patient could see cars in order to drive locally but can¿t read many of the street signs.There are some spots in the distance that patient can see well but walking into the grocery store is overwhelming as nothing is clear.Doctor ended up doing a third surgery to redo the left eye.The third surgery was about three months later.Having that much lapsed time caused surgeon extra concern.The surgeon doesn¿t like the need to put patients through extra surgeries.However the surgeon did it and had no problems.The patient is happy now with her final results.The patient problems now are at dusk/night, needed to put the glasses back on.The patient stated could see very well in the daylight and love that, don¿t need readers to do the close-up puzzles.Additional information received and stated that the surgery had to be redone twice (total of 3 surgeries on os).
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.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.Information was provided that the company 15.5 diopter lens was replaced with another company 14.5 diopter lens.Patient is now happy now with the final results.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, the patient had visual acuity of 20/50 vision.Also had astigmatism and double-vision.The patient could see cars in order to drive locally but can¿t read many of the street signs.There are some spots in the distance that patient can see well but walking into the grocery store is overwhelming as nothing is clear.Doctor ended up doing a third surgery to redo the left eye.The third surgery was about three months later.Having that much lapsed time caused surgeon extra concern.The surgeon doesn¿t like the need to put patients through extra surgeries.However the surgeon did it and had no problems.The patient is happy now with her final results.The patient problems now are at dusk/night, needed to put the glasses back on.The patient stated could see very well in the daylight and love that, don¿t need readers to do the close-up puzzles.Additional information received and stated that the surgery had to be redone twice (total of 3 surgeries on os).

• 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: 13542596
• Report Number: 1119421-2022-00298
• Device Sequence Number: 17110725
• Product Code: POE
• UDI-Device Identifier: 00380652421140
• UDI-Public: 00380652421140
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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: 06/21/2026
• Device Model Number: DFT015
• Device Lot Number: 15221707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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 Age: 70 YR
• Patient Sex: Unknown