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	Glaucoma (1875); Inflammation (1932); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
An ophthalmic surgeon reported that after intraocular lens (iol) implantation, the patient complained of experiencing central scotoma (central vision loss), but once the lights were turned on, everything went back to normal, patient could see everything.The patient was seeing black circles in front of the visual field upon awakening from sleep from the past 2 weeks.The surgeon told that the lens was perfectly centered, vision was good initially after cataract surgery was done.The intraocular lens (iol) had no defect or damage.Yttrium-aluminum-garnet (yag) laser was done to clear any level of posterior capsule opacity (pco).The patient had nonexudative age-related macular degeneration (armd) (early dry stage), yet examination images showed that it was not advanced and all the surgeons who had checked the case said that armd is not the cause for the scotoma.The clinical examination done after implantation also revealed that the patient had toxic maculopathy, glaucoma secondary to eye inflammation (indeterminate stage).Additional information received stated that the lens remains implanted in the patient's eye.There are two medical device reports associated with this patient.This report is associated with the right eye.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Information was provided that the lens was implanted (b)(6) 2022.The patient has early dry age-related macular degeneration (armd).The reporting facility has not provided any further information.File will be reopened if new information is received.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: 17554705
• Report Number: 1119421-2023-01458
• Device Sequence Number: 3640498
• Product Code: POE
• UDI-Device Identifier: 00380652422444
• UDI-Public: 00380652422444
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: 03/02/2026
• Device Model Number: DFT515
• Device Lot Number: 15158222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Male