Abbott Medical Optics Inc (AMO)

FDA Regulatory Profile

Abbott Medical Optics Inc (AMO) appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0530-2015, Class II) was initiated on November 6, 2014.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0530-2015Class IIAbbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL SteNovember 6, 2014
Z-0929-2013Class IIAMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product UDecember 20, 2012