MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Medical Device Problem Codes	Defective Component (2292); Malposition of Device (2616)
Health Effect - Clinical Codes	Macular Edema (1822); Blurred Vision (2137)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There has been 1 other complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that post implantation of an intraocular lens (iol) the patient experienced blurred vision - not correctable; decentered unable to reposition and iol exchange.Post implantation after one month the lens was replaced with other lens.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information requested, received and reported, that the patient experienced cystoid macular edema (cme) and haptic issue.The surgeon prognosis was good.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12319785
• Report Number: 1119421-2021-01563
• Device Sequence Number: 2696313
• Product Code: KYB
• UDI-Device Identifier: 00380652394703
• UDI-Public: 00380652394703
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/17/2021

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: 02/24/2024
• Device Model Number: AU00T0
• Device Lot Number: 15152536
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/21/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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: ACRYSOF MULTIPIECE IOL; DISCOVISC; ACRYSOF MULTIPIECE IOL
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR