# FDA WARNING_LETTER - D.O.R.C. Intl. B.V. - September 12, 2014

Source: https://www.globalkeysolutions.net/records/warning_letter/dorc-intl-bv/61e3ba50-2c57-4ca4-9d5d-c1ea800a022c

> FDA WARNING_LETTER for D.O.R.C. Intl. B.V. on September 12, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: D.O.R.C. Intl. B.V.
- Inspection Date: 2014-09-12
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA inspection of D.O.R.C. (Dutch Ophthalmic Research Center) International B.V. in Zuidland, Netherlands, from September 8-12, 2014, revealed significant violations concerning their Associate 6000 phaco-fragmentation system. The device was found to be adulterated under section 501(f)(1)(B) of the Act because, as a Class III device, it lacked an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. Furthermore, the device was misbranded under section 502(o) of the Act and 21 C.F.R. 807.81(a)(3)(i) due to the firm's failure to submit a new 510(k) notification for significant modifications made to the previously cleared Associate 2500 system. These modifications included changes to cutting speed, lighting, aspiration vacuum, and software, which could significantly affect device safety or effectiveness, potentially leading to tissue heating or damage. As a result of these serious violations, the Associate 6000 systems are subject to refusal of admission into the United States (detention without physical examination). D.O.R.C. International B.V. is required to provide a written response within fifteen business days detailing specific corrective actions, including documentation and a timetable for systemic changes, to address these deficiencies and prevent recurrence.

## Related Officers

- [Jan B. Welch](https://www.globalkeysolutions.net/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)

Company: https://www.globalkeysolutions.net/companies/dorc-intl-bv/f5acbaf3-55a6-4bf8-9414-af636a513cb6

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7