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

Model Number	DFT015
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137)
Date of Event	11/17/2023
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intra-ocular lens (iol) implant procedure, the surgeon noticed white deposits in the iol 8 weeks post-op.Iol looked clear when it was implanted.Patient had corneal oedema post-op, the oedema was clear at 8 weeks post-op which allowed the surgeon to view the iol optic and it was at this time that he noticed the white deposits on the iol.Patient complained of blurry visual acuity and fuzzy vision.Surgeon planning to do an iol exchange.Additional information has been requested.
Event or Problem Description
Additional information has been requested, received and the surgeon stated that patient was doing ok and was being observed.No further treatment was done.
Additional Manufacturer Narrative
The lens was not returned for evaluation.Global quality customer affairs (gqca) reviewed the provided photo.The photograph exhibits findings of individual, small, white-colored focal and gray colored spindle-shaped opacities.As this photo is a 2d image, the illumination is broad, and anatomical landmarks are not present, it is not possible to determine the specific location of these findings.Based on the analysis of this photo alone, the location and identity of these findings cannot be determined.Associated products were not provided.The root cause for the reported deposits could not be determined.Information was provided by the hcp that patient is doing ok and is being observed.No further treatment was done.File will be reopened if new information is provided.The manufacturer internal reference number is: (b)(4).

• 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: 18308679
• Report Number: 1119421-2023-02137
• Device Sequence Number: 6267074
• Product Code: POE
• UDI-Device Identifier: 00380652421249
• UDI-Public: 00380652421249
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DFT015
• Device Lot Number: 15603965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown