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

Model Number	SA6AT3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.No other complaints for lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant surgery, iol was inserted just fine.However when it was unfolded, there was a scratch across the center of the lens.Lens was removed and a new lens was inserted during initial procedure.No patient harm was reported.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
The customer indicated the use of a qualified company cartridge and company handpiece.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge combinations.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 12667093
• Report Number: 1119421-2021-01957
• Device Sequence Number: 1206063
• Product Code: HQL
• UDI-Device Identifier: 00380652335843
• UDI-Public: 00380652335843
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• 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): 12/13/2021

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: 08/31/2022
• Device Model Number: SA6AT3
• Device Lot Number: 12563262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• 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: DUOVISC; MONARCH III IOL INJECTOR; MONARCH III IOL, CARTRIDGE D; DUOVISC; MONARCH III IOL INJECTOR; MONARCH III IOL, CARTRIDGE D
• Patient Sex: Male