MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT40
Medical Device Problem Codes	Failure to Advance (2524); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, a scratch was noted on the lens.There was patient contact with no reported patient harm.Additional information was requested.
Event or Problem Description
Additional information was requested and received stating scratch on lens due to loading issue.
Additional Manufacturer Narrative
Additional information provided in a.1., a.2., a.3., b.5., d.9., d.10., h.3., h.6.And h.10.The lens was returned wrapped in a wet surgical sponge.Solution was dried on the lens.The optic was cut into two portions, typical of insertion and removal.One cut optic portion had a deep scrape mark on the anterior side.The other cut portion of optic had a scuff mark in the shape of an instrument used to grasp the lens.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 complaint may be related to a failure to follow the 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).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11841725
• Report Number: 1119421-2021-01050
• Device Sequence Number: 4503811
• Product Code: MFK
• UDI-Device Identifier: 00380652419079
• UDI-Public: 00380652419079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 06/30/2024
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.120
• Device Lot Number: 12724965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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 CARTRIDGE D; MONARCH INJECTOR
• Patient Age: 68 YR