DRAFT

Doctor
Facility Name
Street
City, State
Country
POSTCODE

URGENT PRODUCT RECALL

Field Correction Underway

Product Details:

Product Description: The Posterior Fluidics Module (PFM), which is an integral component of
the Stellaris® PC Vitrectomy System, regulates the performance of the vitrectomy probe
including residual pressures that involves complete needle retraction of the vitrectomy probe
cutter.

System Name: Stellaris® PC Vision Enhancement System

Serial numbers affected: List attached

Note: This recall is limited to Posterior Fluidics Modules installed at customer sites between
January 3, 2012 and August 8, 2012 with the serial numbers in the attached list.

Dear Valued Bausch + Lomb Customer,

Bausch + Lomb, Inc. recently determined that posterior fluidics modules installed in the Stellaris
PC Vision Enhancement Systems listed above may need to be recalibrated. These modules,
which regulate the performance of the vitrectomy probe, may exhibit behavior that could result
in less efficient aspiration. Although there have been no reports of patient adverse events, there
is a risk of sub-optimal efficiency in aspiration and tissue removal which may result in delayed or
extended surgical procedures. We are thus initiating a voluntary field correction.

According to our records, your facility operates a Stellaris PC system that contains the identified
module. You will be contacted by a field service representative to schedule the exchange of the
module with a validated replacement. Our plan is to complete these field corrections as soon as
possible.

This is a field correction and you may continue to use the Stellaris PC system. As always,
please monitor and report any abnormalities during the surgical procedure.

For regulatory purposes, we require that your facility acknowledge receipt of this
notification. Please FAX the attached sheet with the date of this letter’s receipt noted.

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We sincerely apologize for any inconvenience and assure you that we are working diligently to
resolve this issue in a timely manner. Please feel free to contact technical services with any
questions or concerns: In the UK – Brian Cairns +44 7713 340648

Sincerely,

Signatures

Khalid Raja Denise McEachern

Vice President, Quality Assurance Vice President, Regulatory Affairs
Bausch + Lomb Bausch + Lomb
Khalid.Raja@bausch.com Denise.McEachem@bausch.com

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________________________________________________________________________

Bausch + Lomb Surgical EMEA

106 London Road
Kingston-upon-Thames
Surrey KT2 6TN
FAX: +44 208 781 5550
________________________________________________________________________

Recall and Field Action Acknowledgement Form

Posterior Fluidics Module (PFM) of the Stellaris PC Vision Enhancement System

Fax
This is to acknowledge receipt of the above referenced recall and field action notification dated
August 31, 2012.

Date: ____________________________________________

Message From:
Doctor
Facility Name
Street
City, State
Country
Postcode
Phone Number: ____________________________________________

Message To: Brian Cairns

Company: BAUSCH + LOMB SURGICAL

Fax Number: +44 208 781 5550

Confidentiality Agreement: The information contained in this facsimile message is privileged and
confidential information intended for the use of the addressee listed above. If you are neither the
intended recipient nor the employee or agent responsible for delivering this message to the intended
recipient, you are hereby notified that any disclosure, copying, distribution or the taking of any action in
reliance on the contents of the telecopied information is strictly prohibited. If you have received this
telecopy in error, please immediately notify us by telephone to arrange for the return of the original
document to us.

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UK Module Serial Numbers

PFM00110

PFM00233

PFM00246

PFM00305

PFM00505

PFM00543

PFM00669

PFM00781

PFM00784

PFM00881
PFM00551

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