Company: Surgilight Inc
Product: Optivision Laser System
Date: 4/20/04
Validation of Borland Compiler is incomplete because software used to control passwords was not addressed (FDA 483, Item #3)
Complaint #17 dated December 17, 2001, references software locked up due to possible computer time and/or patient file recreation. Failure not determined
Your firm’s design validation failed to ensure that modified software designed for use with the Scan 195 was appropriate for use with the Optivision Laser System as required by 21 CFR 820.30(g). The software controls the password to allow use of the device when programmed for a specific period of time. A portion of the source code also included questions that were not answered by validation or verification (FDA 483, Item #4).
FDA District: Florida District Office
