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

Model Number SN6AT5

Device Problem Positioning Problem (3009)

Patient Problem Blurred Vision (2137)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.The lens remains implanted.Product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.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 received on (b)(6) 2015.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported worsening and blurred vision following an intraocular lens (iol) implant procedure.She complained of not being able to see the television eight feet away without glasses.The surgeon positioned the lens at 100 degrees, however; reported the lens is currently positioned at 095 degrees.

Manufacturer Narrative

(b)(4).

Event Description

The consumer also reported that she experienced "throbbing off and on" in her eye.She reported that street signs are blurry.

• 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: 5195245
• MDR Text Key: 30131067
• Report Number: 1119421-2015-06522
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.165
• Device Lot Number: 12220129
• Other Device ID Number: 00380652250924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2013
• 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
• Patient Age: 69 YR
• Patient Weight: 75