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

Model Number	DFT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned for analysis.Product evaluation: 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 customer reported, decreased vision following intraocular lens implant.The function of the eye appears to be good but the vision lags behind.The patient is reported to have dry eye from the beginning and visibility decreases during the day.With correction the eye sees well to read but the distant vision cannot be improved.A lens exchange was performed without complications approximately 5.5 months following the initial surgery.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.Light scratches are observed on the lens.A deep scratch is observed in the center of both the anterior and posterior sides of the optic.A power and resolution test was performed with acceptable results.Associated products were not provided.It is unknown if qualified products were used.The root cause for the reported events could not be determined.A malfunction has not been indicated or information provided that the lens was the cause of the event.A power and resolution test was performed with acceptable results.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis.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
Additional information was received reporting that patients first impression was a slight improvement compared to the previous lens.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received reporting dull feeling seems to be less, now possible to read a license plate again.Really need glasses.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating the patient was subjectively satisfied with a spectacle correction.
Additional Manufacturer Narrative
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: 11660817
• Report Number: 1119421-2021-00825
• Device Sequence Number: 3097890
• Product Code: POE
• UDI-Device Identifier: 00380652421737
• UDI-Public: 00380652421737
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/05/2022

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: 04/08/2025
• Device Model Number: DFT315
• Device Lot Number: 15065207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 05/27/2021; 06/22/2021; 07/22/2021; 07/08/2022
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 04/27/2021; 06/18/2021; 06/23/2021; 08/16/2021; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2020
• 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: ACRYSOF IQ NATURAL SINGLEPIECE IOL; ARTELAC; CUSTOM-PAK SURGICAL PROCEDURE PACK; DIAZEPAM 5 MG; DICLOABAK (4 WEEKS); OXYBYPROCAINE/POVIDON IODINE; TOBRADEX (4 WEEKS; TROPICAMIDE/PHENYLEFRINE; VIDISIC GEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male