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Presbia Achieves ISO Medical Device Quality Milestone


Presbia PLC (NASDAQ:LENS), an ophthalmic device company and leader in
near-vision restoration, achieved a major milestone towards complying
with the revised ISO (International Standards Organization) 13485:2016
by successfully completing the ISO 13485:2016 audit with no major
findings. This was an essential step in recertifying under the ISO
standard with annual surveillance audits for the next two years. The
renewal of the company's CE Mark has been completed and is valid through
2022. Notified Body NSAI (National Standards Authority of Ireland)
conducted the audit.

About ISO 13485 Transition from 2003 to 2016

In February 2016 the International Standards Organization (ISO) revised
its medical device standard, ISO 13485:2003 to ISO 13485:2016, placing
greater emphasis on medical device quality management systems (QMS) in
all aspects of product lifecycle. The revised standard provided for a
three-year transition period for medical device organizations to achieve
compliance with ISO 13485:2016. The most significant changes between the
original and revised standard include:

  • Use of risk-based approaches in the context of the safety and
    performance of medical devices meeting regulatory requirements;
  • Additional emphasis on complaint handling and reporting to regulatory
  • Increased emphasis on documentation of corrective actions and
    preventive actions without undue delays;
  • Increased linkage with regulatory requirements and related
  • Increased focus on production of sterile medical devices and related
    sterile barriers in production; and
  • Validation of software, production and supply-chain processes.

Bob Lundberg, Sr. Vice President, Regulatory and Quality of Presbia,
said, "We are extremely pleased that we achieved recertification under
ISO 13485 during the transitional period, and it further demonstrates
our commitment to quality in all aspects of our business."

Forward-Looking Statements

This release contains "forward-looking statements" made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. Information provided and statements contained in this press
release that are not purely historical are forward-looking statements.
These statements are typically preceded by words such as "believes,"
"expects," "anticipates," "intends," "will," "may," "should," or similar
expressions. Such forward-looking statements only speak as of the date
of this press release and Presbia assumes no obligation to update the
information included in this press release. Statements made in this
press release that are forward-looking in nature may involve risks and
uncertainties, including, but not limited to, the factors listed under
"Risk Factors" in our annual report on Form 10-K for the year ended
December 31, 2017, quarterly reports on Form 10-Q, and other reports
that Presbia files with the SEC. Accordingly, readers are cautioned that
any such forward-looking statements are not guarantees and are subject
to certain risks, uncertainties and assumptions that are difficult to
predict. Although Presbia believes that the expectations reflected in
such forward-looking statements are reasonable as of the date made,
expectations may prove to have been materially different from the
results expressed or implied by such forward-looking statements. Unless
otherwise required by law, Presbia also disclaims any obligation to
update its view of any such risks or uncertainties or to announce
publicly the result of any revisions to the forward-looking statements
made in this press release.

About Presbia

Presbia PLC (NASDAQ:LENS) is an ophthalmic device company that has
developed and is currently marketing the presbyopia-correcting Presbia
Flexivue Microlens™, a miniature lens that is implanted in a corneal
pocket created by a femtosecond laser. The Presbia Flexivue Microlens™
has received a CE mark for the European Economic Area, allowing the lens
to be marketed in over 30 countries across Europe. A staged pivotal U.S.
clinical trial for the Presbia Flexivue Microlens™ commenced in 2014.
For more information please visit:

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