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

Model Number SN6AT6

Device Problem Insufficient Information (3190)

Patient Problem Blurred Vision (2137)

Event Date 07/04/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The device remains implanted.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional information by phone and fax.A completed questionnaire was not received.The manufacturer internal reference number is: (b)(4).

Event Description

A technician reported a case of blurred vision and difficulty with night driving due to halos and glare after cataract surgery with an intraocular lens (iol) implant.The device remains implanted.

Manufacturer Narrative

(b)(4).

Event Description

In a follow up the surgeon reported the intraocular lens (iol) to be exchanged for another model.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5374500
• MDR Text Key: 36210503
• Report Number: 1119421-2016-00113
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6U240
• Device Lot Number: 12185279
• Other Device ID Number: 00380652274944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• 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): Other; Required Intervention
• Patient Age: 66 YR