Presbia (Nasdaq:LENS) said today that it has successfully completed the ISO 13485:2016 audit with no major findings.
Officials at the Dublin, Ireland–based ophthalmic device company described the audit completion as an essential step toward recertifying under the ISO standard. The company – which has administrative offices and manufacturing in Irvine, Calif. – will receive annual surveillance audits for the next two years.
“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,” Bob Lundberg, Presbia‘s SVP of regulatory and quality, said in a news release.
Two years ago, the International Standards Organization (ISO) revised its medical device standard, ISO 13485:2003, to ISO 13485:2016. The revision is meant to enhance quality management throughout the medical device lifecycle.
Presbia’s major product is its Flexivue Microlens for treating farsightedness; it’s a miniature lens implanted in a corneal pocket created by a femtosecond laser. The device has a CE mark for sale in the European Union. But Presbia’s stock has taken a major hit since October, when the company said its timeline for FDA approval was delayed because the agency wanted another year’s worth of data on the device.
