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

Model Number	DFT015
Medical Device Problem Codes	Material Opacification (1426); Defective Device (2588)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that during an intraocular lens (iol) implant surgery, the surgeon noticed on the edge of the iol, a sort of "microvacuole" as the edge wasn't "cut" properly and a sort of a bigger "cloud" of "microvacuoles".The iol is properly positioned inside the bag and well centered.Additional information has been requested.
Event or Problem Description
Additional information has been received stating that they did not use company viscoelastic.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
On initial mdr the patient event code of 4581 was an error.It should have been 4582 on the original mdr ¿ (corrected information provided in h.10.).The product was not returned.Global medical safety reviewed the provided photos.Five photos were provided for this case.The photos all appear to be the same but with various amounts of magnification.The photos are a still image taken from a surgical video.The edge of the iol, from about 8 to 11 o'clock, appears to have a slightly roughened surface.Also, in the mid-periphery of the iol (between the tips of the two surgical instruments) there appears to be multiple refractile particles.It is difficult to determine the etiology of these particles.Refractile particles located on the front or back surface of the iol are typically deposits from the aqueous humor.Particles within the body of the iol are referred to as microvacuoles.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated with a non-company viscoelastic.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.No visual issues have been reported for the patient.Determination of edge damage cannot be conducted from the photo.All lenses receive a 100% cosmetic evaluation, which includes the edge surface.Edge damage may occur during delivery if inadequate viscoelastic is used an/ or with rapid delivery.Global medical safety reviewed the provided photos.Mid-periphery of the iol there appears to be multiple refractile particles.It is difficult to determine the etiology of these particles.Refractile particles located on the front or back surface of the iol are typically deposits from the aqueous humor.Particles within the body of the iol are referred to as microvacuoles.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
• MDR Report Key: 11626919
• Report Number: 1119421-2021-00756
• Device Sequence Number: 3292110
• Product Code: POE
• UDI-Device Identifier: 00380652421317
• UDI-Public: 00380652421317
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2025
• Device Model Number: DFT015
• Device Lot Number: 15086381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 07/04/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/14/2021; 07/07/2021
• 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 D CARTRIDGES.; MONARCH III HP.; NOT AN ALCON OVD.