Warning Letter: Failure to report significant software changes (ucm339489)

Tags:

Ofni Systems

Specifically, the Alcon LenSx Laser System was cleared via K101626, with operating software version 2.02. Your firm has since made multiple revisions to the software, and the LenSx Laser System was running software version 2.13 at the time of the inspection. FDA reviewed your software changes from version 2.02 to version 2.13 and determined that some changes are significant with respect to your original premarket clearance submission and may affect the safety and efficacy of the device. A new 510(k) is required for these changes. … It is your responsibility to report to FDA all significant modifications, including software changes that may change the design or performance and/or affect the safety and efficacy of your devices.

View the original warning letter.


Recommended Solutions

Compliance Training >>

Recommended Solutions

ExcelSafe >>

Recommended Solutions

Ofni Clinical >>

Recommended Solutions

Part 11 Toolkit >>

Recommended Solutions

Part 11 Advisor >>

Recommended Solutions

MedWatch Reporter >>

Recommended Solutions

Computer Validation >>

Recommended Solutions

Custom Programming >>

Recommended Solutions

Validating MS Excel Spreadsheets >>

Recommended Solutions

Access Databases >>