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	Failure to Advance (2524)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that during implantation of an intraocular lens (iol) the lens had a crack.Additional information was requested and received stating that lens was stuck in incision and removed without damage.The surgeon made larger incision.In surgeons opinion the loading error contributed to the event.There was no patient harm or hospitalization for the event.
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).

• 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 ; 8007579780
• MDR Report Key: 13423966
• Report Number: 1119421-2022-00160
• Device Sequence Number: 20159475
• Product Code: HQL
• UDI-Device Identifier: 00380652335744
• UDI-Public: 00380652335744
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2026
• Device Model Number: SA6AT3
• Device Lot Number: 15170782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; UNKNOWN VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male