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

Model Number	DAT415
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported following an intraocular lens implant procedure, the lens decentered in the eye which results in decreased vision, images look underwater.The lens was later exchanged in a secondary procedure.Additional information has been requested and received indicating that the actual date the issue was observed.It was also reported that in the surgeon's opinion, the lens did not contribute to event; the cause of the event was due to the patient¿s ¿phimosis.¿ the originally scheduled procedure was completed the same day.There was no patient harm.
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).
Additional Manufacturer Narrative
The product was not returned.Information was provided that indicated the use of a non-qualified cartridge, handpiece, and viscoelastic.The root cause was determined to be unrelated to the lens.Information was provided on the completed questionnaire that the event would be unrelated to the iol.The questionnaire indicated that the event was due to phimosis of the patient's eye after cataract surgery.Additional information indicated that the patient's issues have improved but not totally resolved.The surgeon's prognosis is good, and a future yag procedure may be needed.No further information provided at this time.If additional information becomes available, the file will be reopened and updated.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
• 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: 14674205
• Report Number: 1119421-2022-01249
• Device Sequence Number: 4818480
• Product Code: POE
• UDI-Device Identifier: 00380652427876
• UDI-Public: 00380652427876
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 10/06/2025
• Device Model Number: DAT415
• Device Lot Number: 15105519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF IQ VIVITY TORIC IOL; CARTRIDGE - PLATINUM; HANDPIECE - PLATINUM; VISCOELASTIC - AMYSC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown