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); Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints in the reported lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported a patient with suboptimal vision following intraocular lens implant.The patient reported that the vision decreased after surgery.Additional information is requested.
Event or Problem Description
Additional information was received reporting that patient had vitreous clouding which may partly explain vision.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received, the patient is seeking an additional opinion.
Additional Manufacturer Narrative
Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received reporting, that the lens was explanted.
Additional Manufacturer Narrative
Information was provided, that lens with 18.5 diopter was replaced with a monofocal lens.Surgeon also indicated, that they had seen some vitreous clouding, which may partly explain vision issue.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in a vial with liquid.One haptic is broken-gusset area.The optic is cut into two pieces.Power and resolution testing could not be conducted due to the optic damage.The product history records were reviewed and documentation indicated the product met release criteria.The powerpoint photos provided were reviewed by a director of global quality customer affairs (gqca).Anterior segment tomography: three images provided are unremarkable.Ocular coherence tomography: od: moderately blurry images demonstrating foveal and perifoveal retinal thickening.(b)(6) 2021 image demonstrates a focal area of possible hypoplasia of the retinal pigment epithelium with overlying outer nuclear layer fibrosis.Single-piece, posterior chamber iol clear and well centered in both pictures.No evident anomalies were identified in either picture.The product investigation could not identify a root cause for the reported complaint.The lens was returned in pieces.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 company lens with 18.5 diopter was replaced with a monofocal lens.Surgeon also indicated that they had seen some vitreous clouding, which may partly explain vision issue.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in h.6, result code 3211 was not captured in previous smdr sent.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Information was provided that company lens with, 18.5 diopter was replaced with a monofocal lens.Surgeon also indicated that they had seen some vitreous clouding, which may partly explain vision issue.

• 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
• MDR Report Key: 11516553
• Report Number: 1119421-2021-00582
• Device Sequence Number: 4046926
• Product Code: POE
• UDI-Device Identifier: 00380652421201
• UDI-Public: 00380652421201
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/18/2021

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: 05/31/2024
• Device Model Number: DFT015
• Device Lot Number: 12728744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 05/27/2021; 06/23/2021; 08/30/2021; 09/22/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/12/2021; 06/18/2021; 07/20/2021; 09/21/2021; 10/18/2021
• 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: DIAZEPAM 5 MG; DICLOABAK (4 WEEKS); OXYBUPROCAINE / PROVIDION IODINE; TOBRADEX (4 WEEKS); TROPICAMIDE / PHENYLEFRINE
• Outcome Attributed to Adverse Event: Other; Required Intervention