Bausch & Lomb Recalls SoftPort Easy-Load Lens Delivery System
Bausch & Lomb is recalling specific lots of the SoftPort Easy-Load Lens Delivery System due to reports of kinked haptics during lens delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect (kinked haptics) in a medical device used during eye surgery, which poses a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Bausch & Lomb Surgical, Inc. is recalling specific lots of the SoftPort Easy-Load Lens Delivery System, Model EZ-28V. This sterile, disposable plastic device is used for the folding and delivering of LI61AO, LI61AOV, or LI61SE 3-piece lenses into the eye. The recall is being conducted because of complaints concerning kinked haptics that were occurring during lens delivery.
The affected lots are H671901, H672001, H672602, H674001, H674401, H674801, H675401, H740301, and H743201. These lots have expiration dates ranging from November 2017 to February 2018. The product was distributed nationwide to numerous states and Puerto Rico.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the device is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for consumer action are provided in the source text, as this is a medical device typically used by professionals.
The recalled product
- 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 pull
- Manufacturer
- Bausch & Lomb Surgical, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot Number: H671901 Expiration Date: Dec-17
- Lot Number: H672001 Expiration Date: Nov-17
- Lot Number: H672602 Expiration Date: Dec-17
- Lot Number: H674001 Expiration Date: Dec-17
- Lot Number: H674401 Expiration Date: Nov-17
- Lot Number: H674801 Expiration Date: Dec-17
- Lot Number: H675401 Expiration Date: Dec-17
- Lot Number: H740301 Expiration Date: Dec-17
- and Lot Number: H743201 Expiration Date: Feb-18.
Distribution
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