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 Code	Blurred Vision (2137)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported following the intraocular lens implantation the patient had experienced burred distance and near vision.Hence the lens was explanted in a secondary procedure.
Event or Problem Description
Additional information was received, stating the patient vision not improved after correction.The symptoms were resolved, after replacing the lens.There was no patient harm.Doctor¿s prognosis is good.
Additional Manufacturer Narrative
The lens was returned for evaluation.The lens has been cut in half, typical of insertion and removal from the eye.Solution is dried on the lens.Scratches and marks in the shape of a surgical instrument used to grasp the lens are observed on the optic.A power and resolution inspection could not be conducted, due to extensive damage.The file indicates, the use of a qualified cartridge and handpiece.The file also indicates, the use of a non-qualified viscoelastic.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.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: 14908110
• Report Number: 1119421-2022-01462
• Device Sequence Number: 6197136
• Product Code: POE
• UDI-Device Identifier: 00380652421676
• UDI-Public: 00380652421676
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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: 09/30/2025
• Device Model Number: DFT315
• Device Lot Number: 15103127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/04/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: AMVISC PLUS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown