MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT5
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
An other health care professional reported that after surgery, the patient experienced severe posterior capsular opacification and had a yag laser treatment before to remove pco.Patient has developed cancer and is also now on cancer treatment.Additional information has been requested.There are two medical reports associated with this patient.This file belongs to left eye.Additional information has received it states that the patient¿s vision was good, corrected to 1.2 in right eye.In 2017, noticed the gradual onset symptoms of pco.After yag laser treatment, vision was improved from 0.8 to 1.0 in the left eye, vision cleared up and was good.In 2019 during examination of pco recurrence they noticed slight yellowing of iol, possible opacification starting.In 2022, also had a same finding.So, they have planned a surgery for the patient.
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 LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20214027
• Report Number: 9612169-2024-00897
• Device Sequence Number: 7745652
• Product Code: MJP
• UDI-Device Identifier: 00380652250962
• UDI-Public: (01)00380652250962(17)190531(11)140701(10)21107693(21)21107693023
• 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: 2015
• 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): 10/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.185
• Device Lot Number: 21107693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/14/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/10/2024
• Date Device Manufactured: 07/01/2014
• 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; Other
• Patient Age: 60 YR
• Patient Sex: Male