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

Model Number	SN6AT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Anxiety (2328); Shaking/Tremors (2515)
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 non-health care professional reported following the intraocular lens implantation the patient had experienced glare and strong reflections in both eyes.The patient was also diagnosed with positive dysphotopsia.A lens exchange was performed but it is not clear in which eye the lens was replaced.The patient mentioned it has greatly impacted quality of life and overall health.The patient also had to use many pairs of glasses like tinting, polarization etc.To minimize the light reflections.The product also has caused a great disruption to their daily lives.Additional information has been requested and received stating glare issues in left eye after surgery in certain settings indoor during the day and at night indoors due to lights.Strong reflections/flashes became more noticeable 1-2 months after surgery as i began to experience different environments.Glare and reflections issues became much more noticeable in both eyes in late (b)(6) 2021.Most symptoms occur in the daylight as opposed nighttime.Theses issues have become more disruptive.Additional information has been requested and received stating the patient complained about fluttering of the vision.It was reported that she had about a 3 week history of these complaints.It was unclear to the physician at the time when the patient reported about the initial complaints if these were strictly related to the iol as these had not been noted until several months after surgery.The physician noted a slight head tremor only seen under magnification on at the slit lamp and thought that perhaps this was contributing to her complaints of fluttering.As there are two medical device reports associated with this patient.This report is for left eye.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating the patient has had an acceptable outcome from implantation of the lens, however the positive dysphotopsia issues is the patient day life was very disruptive and is ongoing.It was further communicated that the patient had experienced distress and anxiety since the cataract surgery.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received from the physician stating as the patient had experienced dysphotopsia including fluttering which the patient had found bothersome enough to undergo iol exchanges in both eyes with another surgeon.As there are two medical device reports associated with this patient.This report is for left eye.

• 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: 16982374
• Report Number: 9612169-2023-00381
• Device Sequence Number: 6762780
• Product Code: MJP
• UDI-Device Identifier: 00380652250283
• UDI-Public: 00380652250283
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2023

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: 04/30/2022
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.130
• Device Lot Number: 21192973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 11/08/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 10/11/2023; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• 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; Other
• Patient Age: 62 YR
• Patient Sex: Female