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

Model Number	SN6AT4
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
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 unit manager reported that during an intraocular lens (iol) implant procedure the lens was stuck in cartridge with patient contact.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.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge combinations.The handpiece was not provided.It is unknown if qualified products were used.The manufacturer internal reference number is: (b)(4).

• 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
• 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: 12437395
• Report Number: 1119421-2021-01700
• Device Sequence Number: 14637439
• Product Code: MJP
• UDI-Device Identifier: 00380652250474
• UDI-Public: 00380652250474
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 11/29/2025
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.225
• Device Lot Number: 15118022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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: DUOVISC; MONARCH III CARTRIDGE C; DUOVISC; MONARCH III CARTRIDGE C
• Patient Sex: Unknown