FDA-Device2017-05-17Class II
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Abbott Medical Optics Inc. (AMO)
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.
Sold states
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
Affected count
293,867 units total
Manufactured in
1700 E Saint Andrew Pl, N/A, Santa Ana, CA, United States
Products
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2063-2017Don't want to check this manually?
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