FDA 483 - Beaver Visitec International, Inc. - September 18, 2024

An FDA inspection of Beaver Visitec International, Inc. in Waltham, MA, revealed a significant issue with medical device reporting. The firm failed to submit numerous Medical Device Reports (MDRs) within the required 30-day timeframe. These late reports were associated with adverse events involving ophthalmic surgical knives where the safety shield was not fully engaged in the packaging.