Bausch & Lomb Surgical, Inc. recalls SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, o

Recalled May 24, 2017 · FDA recall Z-2098-2017 · Bausch & Lomb Surgical

Hazard

Complaints concerning kinked haptics that were occurring during lens delivery. · FDA Class II

Sold at

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

Description

Complaints concerning kinked haptics that were occurring during lens delivery.

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.

Manufacturer(s)

Bausch & Lomb Surgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →