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

Model Number	SN6AT4
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported during the intraocular lens implantation debris was noted on the intraocular lens after it was implanted into the eye.The lens was removed and replaced with a back up lens of the same model and diopter.No vitrectomy, suture of lens or incision or incision enlargement was needed.Capsule bag was intact.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in the lens case.Viscoelastic with what appears to be blood was visible on the lens.The lens was cut into two pieces across the center of the optic.One haptic tip was torn/scraped.The material from the damaged area may have been interpreted as the reported foreign material.No foreign material was observed on either haptic or the lens portions.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.One haptic tip was torn/scraped.The material from the damaged area may have been interpreted as the reported foreign material.No foreign material was observed on either haptic or the lens portions.The root cause for the observed haptic damage could no be determined.The damage may have occurred during loading or advancement in the cartridge.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.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 ; 8007579780
• MDR Report Key: 14250879
• Report Number: 1119421-2022-00905
• Device Sequence Number: 20055367
• Product Code: MJP
• UDI-Device Identifier: 00380652250481
• UDI-Public: 00380652250481
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 04/29/2022

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: 07/13/2025
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.230
• Device Lot Number: 15084904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• 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: DISCOVISC.; MONARCH III CARTRIDGE D.; MONARCH III IOL INJECTOR.; ORA SYSTEM WITH VERIFEYE.
• Patient Age: 77 YR
• Patient Sex: Female