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	Macular Edema (1822); Retinal Tear (2050); Visual Impairment (2138)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.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).
Event or Problem Description
A non healthcare professional reported that following implantation of an expired intraocular lens (iol) the patient experienced swollen retina for months.Additional information was received stating that the patient had macular edema which was resolved.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
The product was not returned.Information in the file indicated that the customer implanted the lens after the expiration date.Product history records were reviewed and documentation indicated the product met release criteria.Associated product information was not provided.The root cause for the reported complaint of "expired iol implanted" was determined to be due to a failure to follow the ifu(instruction for use).The ifu instructs to inspect the label and verify the expiration date before opening the product.The reported implant date was (b)(6) 2021.The iol expiration date was 31-aug-2021.This information would indicate that the lens was implanted after the expiration date.Company does not control surgical facility inventory.The patient stated he had macular edema, which has resolved.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stated that patient experienced cystoid macular edema, and a retinal tear that was discovered, after alarming vision problems.Patient was using prescription eye drops and needed to see a retinal expert every few months.
Additional Manufacturer Narrative
New information was provided: on (b)(6) 2021 an expired lens was implanted into the patient.The patient experienced cystoid macular edema, and a retinal tear that was discovered after alarming vision problem in (b)(6) 2022.A year and a half later, the patient must use prescription eye drops in the left eye and be checked by a retinal specialist every few months.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information provided in d.4.Additional information provided in a.4., b.7., d.10.And h.6.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: 14165568
• Report Number: 1119421-2022-00808
• Device Sequence Number: 5908746
• Product Code: MJP
• UDI-Device Identifier: 00380652249911
• UDI-Public: (01)00380652249911(17)210831(11)160930(10)12497133
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/18/2024

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: 08/31/2021
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.210
• Device Lot Number: 12497133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 05/30/2023; 10/22/2024
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/27/2022; 06/26/2023; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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: 2.5 MM DIAMOND BLADE.; 27 GAUGE CANNULA.; BEAVER BLADE.; CORNEAL FIXATION RING.; CYSTOTOME.; HENDERSON TORIC MARKER.; IA HANDPIECE.; JAFFE LID SPECULUMS.; POST-OP MEDICATION: DIAMOX 500 MG.; PROVISC.; UTRATA FORCEPS.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG