FDA 483 - Staar Surgical Company - May 18, 2018

Staar Surgical Co., a medical device manufacturer in Monrovia, CA, received an FDA Form 483 for significant deficiencies in process validation. The firm failed to adequately validate its laser system used for manufacturing Visian Toric Implantable Collamer Lenses, resulting in nonconformances without proper investigation or corrective actions. Additionally, a process qualification report lacked sufficient evidence to support its conclusions, with a high number of scrapped products and no established yield acceptance criteria.