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

Model Number	DFT015
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
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.  additional information was requested however, further information has not been received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that scratches were noticed on the intraocular lens (iol) following implantation.The iol was cut, removed and a back-up lens was implanted.There was no patient harm.Additional information was requested however, further information has not been received.
Additional Manufacturer Narrative
The lens was returned in surgical gauzes.Blood, solution, and surgical gauzes material are dried on the lens.The optic was cut into two portions, typical of insertion and removal.The cut optic portion had small scratches and scuff marks on the anterior and posterior side of the lens.The file indicated the use of a qualified monarch iii (d) cartridge, with a monarch iii handpiece, and a non-qualified viscoelastic.The reported scratches were observed.The root cause for the reported complaint appears to be related to failure to follow the instructions for use (ifu).The file indicated the use of a non-qualified viscoelastic with the lens/delivery system combination used.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.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 ; 8175514979
• MDR Report Key: 12600620
• Report Number: 1119421-2021-01910
• Device Sequence Number: 16987552
• Product Code: POE
• UDI-Device Identifier: 00380652421201
• UDI-Public: 00380652421201
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 07/19/2025
• Device Model Number: DFT015
• Device Lot Number: 15084849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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: MONARCH III CARTRIDGE D; MONARCH III IOL DELIVERY SYST; OVD: HOYA; MONARCH III CARTRIDGE D; MONARCH III IOL DELIVERY SYST; OVD: HOYA
• Patient Sex: Female