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

Model Number	DFT515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that, following the intraocular lens (iol) implant procedure, the patient had had a visual acuity of 5/10 and an astigmatism of 2 at day 3 of post-operation.The surgeon checked the implant centering and the biometer calculations and there is nothing to report from these.On day 10, the patient was still at 5/10, so the surgeon exchanged with non-company iol.The patient and wanted us to analyze the lens to see if the implant had the right power, i.E.+20.5 diopters.Additional information received and stated at day 3 va was 6/10 sc with a little edema additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a clear liquid inside a specimen cup.The optic was cut from edge past center, which is typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Product history records were reviewed and 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 for the reported complaint.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 lens 20.5 d (1.5 extended depth of focus) lens was replaced with a non- company toric lens.The patient's visual acuity before the replacement was indicated to be 5/10 and an astigmatism of 2.The visual acuity after the replacement was indicated to be 6/10.The diopter and toric power of the replacement lens was not provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC 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: 17920003
• Report Number: 1119421-2023-01736
• Device Sequence Number: 16846675
• Product Code: POE
• UDI-Device Identifier: 00380652422475
• UDI-Public: 00380652422475
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2023

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: 08/11/2026
• Device Model Number: DFT515
• Device Lot Number: 15247735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ZEISS TORBI IMPLANT REPLACEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female