MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause has not been identified.Additional information was requested.A questionnaire was received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during the intraocular lens (iol) implant procedure the lens had to be cut out of the eye as there was a scratch on it.Additional information was requested and received.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution is dried on the lens.The optic is cut into two portions, typical of insertion and removal.Both cut optic portions has cracks, scratches, and deep scrape marks 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.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).
Additional Manufacturer Narrative
Additional information provided in b.5.
Event or Problem Description
Additional information was received stating that patient issue was resolved with no hospitalization and harm to the patient.The prognosis was also good.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11968636
• Report Number: 1119421-2021-01185
• Device Sequence Number: 4339143
• Product Code: MJP
• UDI-Device Identifier: 00380652249843
• UDI-Public: 00380652249843
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2021

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: 10/07/2025
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.175
• Device Lot Number: 15105095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/04/2021; 07/19/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/13/2021; 08/10/2021
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 47 YR