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

Model Number	DFT515
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the iol became dislocated.The iol was removed in a secondary procedure.Additional information was provided by the surgeon that the posterior capsule appeared intact prior to inserting the lens, when rotating the lens, a posterior tear was noted and the lens fell in to the vitreous.The eye was closed and the patient was sent to a retina specialist for evaluation the same day.The iol was exchanged the next day.In the surgeon's opinion, the iol did not cause the event.The event was caused by the posterior capsular tear.There was no patient harm, the patient's issues have resolved and the prognosis is good.There is a mild resolving vitreous hemorrhage.
Additional Manufacturer Narrative
Product evaluation: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge.Two non-qualified viscoelastics were indicated.The product investigation could not identify a root cause for the reported complaint.The root cause may be unrelated to the product.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
• MDR Report Key: 11915146
• Report Number: 1119421-2021-01133
• Device Sequence Number: 14469613
• Product Code: POE
• UDI-Device Identifier: 00380652422536
• UDI-Public: 00380652422536
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2025
• Device Model Number: DFT515
• Device Lot Number: 15075144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: AMVISC; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; OCUCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR