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	Malposition of Device (2616)
Health Effect - Clinical Codes	Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for lens not being at the intended axis.It is unclear if the lens was initially placed-off axis or if it rotated after surgery.The subsequent post-of refraction issues were related to the lens axis.A director of (b)(4) reviewed and discussed the provided patient information with the surgeon.Based on the provided biometries, the lens appeared to be at to be at the wrong toric axis.The surgeon confirmed that the lens was at 30 degrees, which was 90 degrees off target.This position would account for the post-op refraction results.Follow-up information was provided by the surgeon that the lens was repositioned and the patient did well.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that following implantation of an intraocular lens (iol) patient experienced poor vision, lens malposition unexpected outcome with both spherical and cylinder and the refractions was at -3.50 +4.50 at 135.Additional information was obtained reporting that the lens was repositioned and the patient did well.
Additional Manufacturer Narrative
The previous report submitted for this event contained an error, in h.1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

• 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: 11422885
• Report Number: 1119421-2021-00485
• Device Sequence Number: 4711345
• Product Code: POE
• UDI-Device Identifier: 00380652428798
• UDI-Public: 00380652428798
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 03/03/2025
• Device Model Number: DAT515
• Device Lot Number: 15049588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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: MONARCH III IOL DELIVERY SYSTEM; PROVISC; MONARCH III IOL DELIVERY SYSTEM; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention