MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number SN6CWS

Device Problem Insufficient Information (3190)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 06/20/2015

Event Type  Injury  

Event Description

Following an intraocular lens (iol) implant surgery, a consumer reported foggy vision and a smudge on anterior surface of iol.The iol was explanted and symptoms were resolved.Another iol was implanted.Attempts have been made to obtain additional information by phone and fax.A completed questionnaire was received.

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.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.Zip code is not indicated at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Device evaluation: the lens was returned with solution, broken haptic damage and split/cracked optic damage.This may have been interpreted as the reported complaint.Results from the product history record review indicated the product met release criteria.The file indicated that the complaint lens was replaced with another lens of same power and model due to the patient complaining of foggy vision.Based on our observation it can be reasonably concluded that the lens damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The root cause of the mentioned foggy vision may be related to the presence of the observed optic damage.There are no other complaints in this lot.Investigation has been completed based on current information.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: 4957120
• MDR Text Key: 6638725
• Report Number: 1119421-2015-05970
• Device Sequence Number: 1
• Product Code: KYB
• 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,consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/26/2015

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.200
• Device Lot Number: 12340951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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: 67 YR
• Patient Weight: 79