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

Model Number	DAT515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.One other complaint for lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced decreased vison and refractive surprise.The iol was exchanged in a secondary procedure.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stated that the poor vision was present from (b)(6) 2021 post operation day 1, however the decision was not made to exchange the iol until (b)(6) 2021.The iol was exchanged for another same lens model with same diopter 6 months following the initial implant procedure.There was no patient harm.

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12184514
• Report Number: 1119421-2021-01394
• Device Sequence Number: 952133
• Product Code: POE
• UDI-Device Identifier: 00380652428798
• UDI-Public: 00380652428798
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Model Number: DAT515
• Device Lot Number: 15049588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/16/2021
• 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: DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR