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

Model Number	DAT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.Additional information was requested.(b)(4).
Event or Problem Description
A customer reported that following implantation of an intraocular lens (iol) patient had difficulty adjusting to depth of focus lens and was not happy with the vision.Lens was exchanged in the secondary procedure with a non company lens.Additional information was requested.
Additional Manufacturer Narrative
The lens was retuned in a non-company (replacement) lens case.Solution was dried on the lens.Both haptics were bent in the gusset and distal area.The optic was cut into two portions, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of qualified associated products.There were no other complaints reported in the lot number.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the company, 20.5 diopter lens model was replaced with a competitors monofocal 24.0 diopter lens model, due to a patient having difficulty adjusting to the depth of focus lens.The patient had pre-existing ocular conditions of dry macular degeneration, dermatochalasis, blepharitis, 1+spk dry eye, pvd, and small to medium drusen.Additional information was provided that the patient had difficulty adjusting to depth of focus lens and was not happy with vision os 1 week after cataract extraction.After surgery od with single focus lens, patient wished to proceed with lens exchange os for single focus lens set for near 2.25.The company lens model delivers monofocal quality distance and excellent intermediate vision, however the patient and surgeon decided that the selection of a single focus lens set for near was a better fit for the patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11435375
• Report Number: 1119421-2021-00498
• Device Sequence Number: 4014955
• Product Code: POE
• UDI-Device Identifier: 00380652424646
• UDI-Public: 00380652424646
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 03/08/2025
• Device Model Number: DAT015
• Device Lot Number: 15049481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY; MONARCH III IOL DELIVERY SYSTEM; MX60E; PROVISC; VISCOAT; MONARCH III IOL DELIVERY; MONARCH III IOL DELIVERY SYSTEM; MX60E; PROVISC; VISCOAT
• Outcome Attributed to Adverse Event: Required Intervention