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

Model Number	DFT315
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Macular Edema (1822); Retinal Detachment (2047); Visual Impairment (2138); Capsular Bag Tear (2639)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not 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 one other complaint reported in the lot number.Additional information was requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported explantation of an intraocular lens (iol) due to poor vision and iol instability.A capsular tear occurred and the patient experienced a retinal detachment during the initial intraocular lens implant procedure.Retinal detachment repair was performed and the iol was exchanged with an anterior chamber iol.The patient has some macular edema but the prognosis is good.The surgeon indicated that the iol did not cause or contribute to the reported event; however, further information was not provided.

• 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
• MDR Report Key: 12255318
• Report Number: 1119421-2021-01499
• Device Sequence Number: 17098176
• Product Code: POE
• UDI-Device Identifier: 00380652421591
• UDI-Public: 00380652421591
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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: 02/18/2025
• Device Model Number: DFT315
• Device Lot Number: 15039047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/30/2021
• 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: ANTERIOR CHAMBER PMMA; MONARCH III, CARTRIDGE D; MONARCH III, INJECTOR; PROVISC OPHTHALMIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR