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

Model Number SN6AT3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Sensation in Eye (1869); Headache (1880); Pain (1994); Blurred Vision (2137); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that following an intraocular lens (iol) implant procedure, the eye felt uncomfortable, sore and painful.Feels like wearing a contact lens, foreign body sensation and that people can see reflection of the iol.Additional information was provided by the consumer, who reported that she is still blurry, feels off like unbalanced.When looking at a light she sees a beam flashing down.She was having headaches that she had to have an mri.No findings on the mri.The consumer reported being diagnosed with a "lazy eye".She was told by her doctor that everything was fine, but she knows that something is wrong.The consumer went to another doctor and was told she was overcorrected.Five months after the initial implant procedure, the other doctor performed a photo refractive keratectomy (prk).The consumer thinks that the doctor implanted the wrong lens.She reported that this is disabling.Additional relevant test data and relevant history were provided by the surgeon.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 9240001
• MDR Text Key: 163802591
• Report Number: 1119421-2019-01792
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.265
• Device Lot Number: 12593793
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention