Recall Z-1597-2016 ยท HQC Unit, Phacofragmentation
Alcon Research, Ltd.
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
| Date | May 3, 2016 (initiated Oct 6, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 6597 packs |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021566 | INFINITI Alcon Laboratories, Inc., Jul 2, 2002 |