Recall Z-1597-2016— Alcon Research, Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research, Ltd., initiated 2014-10-06, terminated 2017-03-31. It names one FDA 510(k) clearance: K021566. Product: INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.. Reason: The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-06
- Terminated
- 2017-03-31
- Firm location
- Fort Worth, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Reason for recall
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.