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

Model Number	DFT515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information was requested and received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that following implantation of an intraocular lens (iol), a small divet was noted on posterior surface of the iol.The lens was remained implanted and surgeon not concerned regarding visual acuity outcome.
Additional Manufacturer Narrative
The product was not returned.A photo was provided of a computer monitor displaying a lens in the eye.There is a red circle drawn around a gray spot near the center of the optic.Due to the quality and lighting of the photo, the origin of the spot cannot be determined at any magnification.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified cartridge and handpiece.The customer indicated the use of a viscoelastic, which is not qualified for cartridge use.Based on our observation of the attached photo, there may a spot/mark on the lens.It is difficult to make a final determination without evaluation of the physical sample.The root cause may be related to a failure to follow the dfu.The viscoelastic indicated is not qualified for the lens/cartridge combination used.Due to differing material properties, the use of an non-qualified viscoelastic may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11896981
• Report Number: 1119421-2021-01119
• Device Sequence Number: 1284915
• Product Code: POE
• UDI-Device Identifier: 00380652422420
• UDI-Public: 00380652422420
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 09/30/2024
• Device Model Number: DFT515
• Device Lot Number: 12751472
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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 INJECTOR; MONARCH III, CARTRIDGE D; OVD- ZEISS TWINVISC