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.
Reported: May 24, 2017 Initiated: April 5, 2017 #Z-2098-2017
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.
Details
- Recalling Firm
- Bausch & Lomb Surgical, Inc.
- Distribution
- Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bausch & Lomb Surgical, Inc..
Why was this product recalled? ▼
Complaints concerning kinked haptics that were occurring during lens delivery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Moderate. Recall number: Z-2098-2017.
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