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

Model Number SN6AT5

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

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that following bilateral intraocular lens (iol) implant procedures she has experienced discomfort and has not gotten satisfaction from the implants.Additional information was provided by the consumer that she had a yag laser procedure.She reports that she has also experienced dry eyes, double vision and eye strain since the implantation of the lenses.She has had several pairs of glasses that just don't help.She reports that the correction was worth it.There are two medical device reports associated with this patient.This report is for the right eye.

• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10341271
• MDR Text Key: 200965040
• Report Number: 1119421-2020-01075
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.215
• Device Lot Number: 12015362
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2011
• 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