Recall Z-3267-2018— Bausch & Lomb Inc
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Inc, initiated 2018-08-08, terminated 2019-08-28. It names one FDA 510(k) clearance: K162342. Product: Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.. Reason: The back cap separates from the body of the vitrectomy cutter..
- Recalling firm
- Bausch & Lomb Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-08
- Terminated
- 2019-08-28
- Firm location
- Saint Louis, MO, 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
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
Reason for recall
The back cap separates from the body of the vitrectomy cutter.
Data sourced from openFDA. This site is unofficial and independent of the FDA.