Recall Z-2098-2017— Bausch & Lomb Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Surgical, Inc., initiated 2017-04-05, terminated 2019-12-11. It names one FDA 510(k) clearance: K970727. Product: SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.. Reason: Complaints concerning kinked haptics that were occurring during lens delivery..
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-05
- Terminated
- 2019-12-11
- Firm location
- Clearwater, FL, 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
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.
Reason for recall
Complaints concerning kinked haptics that were occurring during lens delivery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.