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

Model Number	DFT015
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, the patient was incompatible with the iol.First the iol had a minimal tilt and the patient visual acuity was 20/32.After rotation the visual acuity get worse.The iol was exchanged for another lens model 1 months following the initial implant procedure.There is no patient harm and the visual acuity is recovered now.Additional information has been received and stated that visual acuity was found at 0.4 decimal (20/50) which was found on (b)(6) 2022.No further information available.

• 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: 13952083
• Report Number: 1119421-2022-00641
• Device Sequence Number: 12407486
• Product Code: POE
• UDI-Device Identifier: 00380652421225
• UDI-Public: 00380652421225
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2026
• Device Model Number: DFT015
• Device Lot Number: 15214874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INJECTOR: ASICO; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; OVD HEALON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male