AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviole
FDA device recall Z-0929-2013 · posted 2013-03-09 · Terminated
Recall details
- Recalling firm
- Abbott Medical Optics Inc (AMO)
- Reason for recall
- Two production orders of these IOLs that contain mislabeled IOLs.
- Action taken
- AMO sent an Urgent Field Safety Notice letter to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to stop using and remove affected product from inventory. The letter advice customers to complete and return the enclosed Facsimile Form. For questions contact AMO Customer Service Representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- 155 units
- Distribution
- Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.
- Date initiated
- 2012-12-20
- Date posted
- 2013-03-09
- Date terminated
- 2014-01-08
- Location
- Santa Ana, CA
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