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

Model Number	SN6AT4
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported following an intraocular lens implant procedure, the patient experienced blurred vision.The lens was exchanged in a secondary procedure and the clinical reason for explant was flipped axis with toric lens.Additional information has been requested which states there was no patient harm.
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 number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
As per the follow up information, the reporter is no more suspecting the intraocular lens.

• 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: 15269217
• Report Number: 9612169-2022-00409
• Device Sequence Number: 12380920
• Product Code: MJP
• UDI-Device Identifier: 00380652250443
• UDI-Public: 00380652250443
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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 Expiration Date: 04/30/2023
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.210
• Device Lot Number: 21216603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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.; CLAREON MONARCH IV IOL DELIVERY SYSTEM.; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; ORA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female