Recall Z-1597-2016
Alcon Research, Ltd. · initiated October 6, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Codes / lots: Lot numbers: 1623139H, 1623140H, 1623138H, 1623141H, 1623765H, 1623148H, 1623766H, 1623767H, 1623768H, 1623142H
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.
FDA-determined cause: Process change control
Action taken
The recalling firm notified affected customers on 10/6/2014 via a customer letter with an attached Medical Device Removal Response Form. On 10/23/2014, a second notification was sent to 76 customers who did not respond to the initial notification.
Details
- Recall number
- Z-1597-2016
- Initiated
- October 6, 2014
- Posted by FDA
- May 3, 2016
- Terminated
- March 31, 2017
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 6597 packs
- Distribution
- Nationwide Distribution.
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX