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

Model Number	DAT515
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure the physician noticed a scratch on lens after insertion into eye.The lens was removed from eye during same procedure.Additional information was requested and received.The procedure was completed on same day by exchanging iol with no patient harm.
Additional Manufacturer Narrative
The lens case was returned fully disassembled in a plastic bag.The lens was returned positioned incorrectly in the lens case.Blood and solution was dried on the lens.The lens was cut into two portions, typical of insertion and removal.One cut optic portion had a deep scrape mark on the anterior side of the optic.All product and batch history records are quality reviewed prior to product release.The file indicated the use of a qualified cartridge with a non-qualified viscoelastic.The reported lens damage was observed.The root cause for the reported complaint appears to be related to failure to follow the instructions for use (ifu).A non-qualified viscoelastic was 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 TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12432039
• Report Number: 1119421-2021-01689
• Device Sequence Number: 3726339
• Product Code: POE
• UDI-Device Identifier: 00380652428835
• UDI-Public: 00380652428835
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 03/09/2025
• Device Model Number: DAT515
• Device Lot Number: 15057714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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: AMVISC PLUS; MONARCH III CARTRIDGE D