Numerous complaints involving the possible malfunction of diagnostic contact lenses were overlooked by Volk Optical, according to a recent FDA warning letter.
In its response to Form 483 observations, Volk indicated it would reevaluate and inspect the three complaints listed by an FDA investigator. But the investigator had used those complaints only as examples, the warning letter says, and Volk was required to complete failure investigations for all 19 complaints sampled for review. That sample was taken from 1,070 complaints received by Volk within the past year.
Every complaint must be reviewed to determine if additional failure investigations or corrective actions need to be taken, the letter says.
The company also was cited because its complaint procedure failed to follow FDA requirements for analyzing sources to identify existing and potential malfunctions of the devices in question. This procedure should include analyzing the types of complaints and the reasons for returns.
The letter adds that Volk lacked thorough documentation for all steps in its complaint procedure. As part of its response, Volk said its complaint-handling procedure would be revised and implemented. The FDA requested copies of the new procedure for a follow-up review.
The warning letter is available at www.fda.gov/foi/warning_letters/s6859c.pdf.