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

Model Number SN6AT5

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

Patient Problem Increased Sensitivity (2065)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The results from the product history record review 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.Attempts have been made to obtain additional information.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that he is having trouble with bright lights and driving is difficult following cataract surgery with bilateral intraocular lens (iol) implants.He had photo refractive keratectomy after cataract surgery in both eyes, and a history of myopic degeneration.He also reported having a yag laser.There are two medical device reports associated with this patient.This report is for the left eye.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7186066
• MDR Text Key: 97099209
• Report Number: 9612169-2018-00010
• 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: Patient
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.060
• Device Lot Number: 21136377
• Other Device ID Number: 00380652250719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2017
• Date Device Manufactured: 07/10/2015
• 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