URGENT: FIELD SAFETY NOTICE

a Novartis company
URGENT: FIELD SAFETY NOTICE
Date: <<date>>
Commercial Name
Sterile Single-Use Bipolar Forceps
of Affected
Product:
Reference(s):
Code 8065129501 : Lot 061814-95
Code 8065129101 : Lot 080614-91
FSCA Identifier: 2014.099
Type of Action: Medical Device recall
November XX, 2014
«ACCOUNT_NAME»
«ADDRESS_1»
«CITY»«ST»,«POASTAL_CODE»
«CALLER_NAME»
Dear Valued Alcon Customer,
Alcon is conducting a Field Safety Corrective Action (FSCA) on two lots of Single-Use Bipolar Forceps
due to not being sterilized prior to distribution. No adverse events or complaints have been reported. Use
of non-sterile forceps in surgery has the potential to pose a safety risk to patients. Alcon is committed to
patient safety and the quality of its products.
We have identified that you have recently received stock of Alcon Single-Use Bipolar Forceps from one or
more of the following identified lot numbers:
List of Affected Devices / Lots
Lot Number
Catalog Number
061814-95
080614-91
8065129501
8065129101
Description
Alcon Single-Use Straight Bipolar Forceps
Alcon Single-Use Curved Iris Bipolar Forceps
National Competent Authorities will be advised of this action.
Details on Affected Device:
Sterile Single-Use Bipolar Forceps are electrosurgical coagulation handpieces intended to remove tissue
and control bleeding by use of high-frequency electrical current, a process also known as bipolar
diathermy.
The bipolar device is connected to a bipolar cable, which interfaces with the
coagulation/diathermy system on the console. The forceps, when used with an appropriate connecting
cord, are qualified for full compatibility with the Alcon Bipolar Coagulator, Phaco-Emulsifier and/or
Vitreoretinal surgical systems.
Description of the Problem:
Quality review processes showed the two identified lots were not sterilized prior to distribution. We are
conducting this Field Safety Corrective Action due to the fact that the potential possibility exists that the
use of non-sterile forceps in surgery may pose a safety risk to patients.
There are no known complaints that involved physical injury or damage to any person related to this
issue. Records indicate that you may have received units from these Lots.
a Novartis company
Actions to be taken by the Customer/ User:
To assist us in this FSCA, please take the following steps:
1.
2.
3.
4.
5.
Immediately stop further use of the affected lots of Single-Use Bipolar Forceps.
Review your inventory to determine if you have any affected units (refer to table above)
Segregate the potentially-affected product to ensure it is not used
Return the attached Response Form via fax or email to Alcon
Please fill out and return the attached “Response Form” even if you have zero (0) units in
inventory
Please Note: Replacement stock will be issued for units that are returned to Alcon. An Alcon Customer
Service Representative will work with you to place a new order to replace the affected units. Please
contact local Alcon Customer Service Agent to arrange for the return of your inventory.
Transmission of this Notice:
Please immediately forward this information to all departments within your organization who may be using
or ordering the Alcon Single-Use Bipolar Forceps. Additionally, please ensure that a copy of this
notification is provided to any other organizations to which the affected device lots have been transferred.
Contact reference person:
We appreciate your cooperation and sincerely regret any inconvenience that this may cause you. We
hope this action reassures you of our commitment to provide you with the highest quality vision care
products and continued quality excellence for you and your patients.
Should you have any questions or concerns about this matter, please contact Franziska Leu at 041 763
77 57..
Sincerely,
Markus Reut
Head of Market Access & Regulatory Affairs
Alcon Switzerland SA
Suurstoffi 14, CH-6343 Rotkreuz, Switzerland
T +41 41 763 7740 | Fax +41 58 911 37 04 | M +41 79 848 60 65
[email protected]
a Novartis company
Response Form
Please follow these important steps:
1. Immediately stop further use of the affected lots of Single-Use Bipolar Forceps.
2. Review your inventory to determine if you have any affected units:
List of Affected Devices / Lots
Lot Number
Catalog Number
061814-95
080614-91
8065129501
8065129101
Description
Alcon Single-Use Straight Bipolar Forceps
Alcon Single-Use Curved Iris Bipolar Forceps
3. Segregate the potentially-affected product to ensure it is not used
4. Return the attached Response Form via fax or email to Alcon
5. Please fill out and return the attached “Response Form” even if you have zero (0) units
in inventory
[email protected] / 0844 82 82 90
Please return the Response Form even if you do not have any inventory from these
lots. Your signature bellow attests that you have read and understood Alcon’s
request and instructions.
Please contact your local Alcon Customer Service Agent to arrange for the return of your inventory.
Catalog Order #
Signature of Facility Representative:
Printed Name and Title:
Date:
«ACCOUNT_NAME»
«ADDRESS_1»
«CITY»«ST»,«POASTAL_CODE»
«CALLER_NAME»
«CALLER_PHONE»
«ACCOUNT_»
Lot ID
# Units in Inventory