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

Model Number	SN6AT3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Adhesion(s) (1695); Corneal Clouding/Hazing (1878); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient stated that right eye has calcium phosphate on the posterior surface of the lens.The surgeon has been put on steroid drops qid x 1 month, now is on tid.The patient has also taken a corticosteroid dose pack.Consumer notes the surgeon told him he had some clouding of the vitreous but has not seen a retinal surgeon.Additional information has been received and stated that, the patient had glistenings.The patient also states he previously had yag and had posterior synechiae that yag was supposed to treat.
Additional Manufacturer Narrative
The product investigation could not identify a root cause for the reported complaint.The product was not returned.The reporter was the patient.The patient¿s surgeon provided information that symptoms far exceed the amount of glistening present in the lens.Patient was sent to a retinal surgeon, cleared by retina.Surgeon stated consumer has had yag and referred to a specialist.The surgeon stated there was not enough glistening present to warrant a photo.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information has been received from the surgeon and stated that, the patient had vitrectomy (as per the patient).The lens was explanted in a secondary procedure.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that, consumer is going to have topographical prk (photorefractive keratectomy) done to correct residual astigmatism.
Additional Manufacturer Narrative
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: 18045927
• Report Number: 1119421-2023-01850
• Device Sequence Number: 15473271
• Product Code: MJP
• UDI-Device Identifier: 00380652249942
• UDI-Public: 00380652249942
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.225
• Device Lot Number: 12549918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 02/21/2024; 03/20/2024; 05/16/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/29/2023; 03/19/2024; 04/16/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male