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

Model Number	SN6AT3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); Corneal Endothelial Cell Loss (4806)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation, the surgeon noticed a defect to the optic - a small crater in the anterior surface of the iol.The iol was left in place because patient had history of fuchs and small pupil at baseline.Next day the patient had visual acuity score of 20/30, but the defect was unchanged, located at iris margin even after dilating drops.The patient was happy.The surgeon could also see the guttata in patient's eye.According to additional information received, the defect was peripheral and not visually-significant.The prognosis was excellent with regards to the iol.The patient had fuchs corneal dystrophy, which limited his best corrected visual acuity (bcva) and might progress.This was not impacted by the lens defect.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.A photo was provided of the patient¿s eye.The haptics were not visible.Unable to determine, the orientation of the lens.A large artifact was observed, at the 8 o¿clock position.It cannot be determined, if this is lens damage.The artifact appears to be on top of the lens.Lines were observed, near the artifact that may be scratches.If so, this could indicate, a plunger override occurred.Unable to determine, the nature or origin of the artifact from the photo.Product history records were reviewed and documentation indicated, the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.A photo was provided.A large artifact was observed, at the 8 o¿clock position.It cannot be determined, if this is lens damage.The artifact appears to be on top of the lens.Lines were observed, near the artifact that may be scratches.If so, this could indicate, a plunger override occurred.Unable to determine, the nature or origin of the artifact from the photo.If the lens is folded per the instructions for use (ifu), the anterior surface does not contact the inner lumen of the cartridge anterior surface, damage can be caused by a plunger override.Information was provided, that the patient is happy and has no issue.File will be reopened, if new information is received.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: 19097342
• Report Number: 1119421-2024-00694
• Device Sequence Number: 20689974
• Product Code: MJP
• UDI-Device Identifier: 00380652249843
• UDI-Public: 00380652249843
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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 Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.175
• Device Lot Number: 15480389
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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 DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED FORCEPS
• Patient Sex: Unknown