FDA-Device2016-05-11Class II
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Alcon Research, Ltd.
Hazard
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
Sold states
Nationwide Distribution.
Affected count
6597 packs
Manufactured in
6201 South Fwy, Fort Worth, TX, United States
Products
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1597-2016Don't want to check this manually?
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