FDA WARNING_LETTER - Molteno Ophthalmic Limited - October 30, 2014

On February 27, 2015, the FDA issued a Warning Letter to Molteno Ophthalmic Limited following an inspection from October 28-30, 2014. The inspection revealed that the firm's S-series glaucoma drainage implants are adulterated because they lack an approved premarket approval (PMA) or investigational device exemption (IDE). Additionally, the devices are misbranded as the firm failed to notify the FDA of its intent to commercially distribute them.

Specifically, the firm modified its G-series glaucoma drainage implants (cleared under K062252) by altering the pressure ridge, increasing plate surface area, and repositioning suture holes. These changes, impacting device performance, safety, and effectiveness, necessitate a new 510(k) submission.

The inspection also identified quality system deficiencies, including failure to establish and maintain procedures for design change validation/verification (21 CFR 820.30(i)). For example, modifications to the G-Series implants in 2011 were not validated or verified, and pyrogen testing did not evaluate endotoxin levels for all relevant implant segments. The firm's response regarding this was deemed inadequate.

Furthermore, the firm failed to establish and maintain procedures for quality audits conducted by individuals without direct responsibility for the audited matters (21 CFR 820.22). The General Manager audited areas under her direct responsibility