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

Model Number	DFT015
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly (posterior surface up) in the lens case inside the opened peel pouch placed inside the opened carton.Solution was dried on the lens.One haptic has a deep scrape mark across the anterior surface of the distal tip.The damage was similar in appearance to lens case related damage.The lens would have been originally placed anterior surface up in the lens case.Product history records were reviewed and the documentation indicated the product met release criteria.The viscoelastic information was not provided.The root cause cannot be determined for the complaint.One haptic has a deep scrape mark across the anterior surface of the distal tip.The damage was typical in appearance to lens case related damage.Based on the observation of the damage location on the anterior surface, this suggests the lens has been replaced into the lens for return shipment.The presence of the solution on the returned sample was evidence that the product was subjected to handling.Due to the presence of surgical solution, we are unable to verify that the damage was present when opened.There was one other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported with description of defective intraocular lens (iol).Additional information has been requested.

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13926373
• Report Number: 1119421-2022-00606
• Device Sequence Number: 13897912
• Product Code: POE
• UDI-Device Identifier: 00380652421225
• UDI-Public: 00380652421225
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2025
• Device Model Number: DFT015
• Device Lot Number: 15106907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown