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

Model Number	SN6AT5
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that following the implant procedure, the patient complaint about a scratch on the lens.The scratch was influencing his vision.The lens was planned to remove.Additional information was received and stated that, post cataract surgery (with iol implant) 1 week follow up, it was found that the lens that was inserted presented with a mark in the optic of the lens, affecting the patients vision.The iol was exchanged in a secondary procedure.The issue has been resolved.
Additional Manufacturer Narrative
Additional information provided in d.10.And h.10.Qualified associated products were indicated.The product investigation could not identify a root cause.The reported scratch was causing the vision issues which caused the need for explant.The lens was replaced with the same lens model with a half diopter difference.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: 16077323
• Report Number: 1119421-2022-02777
• Device Sequence Number: 12330992
• Product Code: MJP
• UDI-Device Identifier: 00380652250986
• UDI-Public: 00380652250986
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.195
• Device Lot Number: 15330079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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: ACRYSOF IQ TORIC SINGLEPIECE IOL; DISCOVISC; MONARCH; MONARCH CARTRIDGE D; MONARCH INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male