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

Model Number	DFT315
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: the lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.Both haptics were bent in the gusset and distal area.The optic was torn/split/cracked and cut into three portions, typical of insertion and removal.The three cut optic portions was scratched on the anterior and posterior sides of the lens.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.There were no other complaints in this lot.Information was provided that indicated the use of a qualified cartridge and handpiece.A non-qualified viscoelastic was used.The root cause for the reported event/issue may be related to a failure to follow the directions for use (dfu).The reported scratch was observed.The viscoelastic indicated is not qualified for the lens/cartridge combination used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgical technologist reported that during a cataract extraction with intraocular lens (iol) implant procedure that the iol was scratched.Additional information was provided that the scratch was noted when the lens was implanted.Further information was provided that the iol was removed during the initial procedure.

• 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: 11769664
• Report Number: 1119421-2021-00952
• Device Sequence Number: 17185593
• Product Code: POE
• UDI-Device Identifier: 00380652421676
• UDI-Public: 00380652421676
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 05/19/2025
• Device Model Number: DFT315
• Device Lot Number: 15073894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/04/2021
• 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: ANKIVISC; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Age: 57 YR