FDAFDA · Food and drugs·Recall number Z-2065-2017
Healon 5 Pro, Part No. 10270015
Published May 17, 2017 · Recall initiated: April 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Distributor
- US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador
- Lot
- UB32526
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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