Z-2098-2017 Class II Terminated
FDA device recall Z-2098-2017 was initiated by Bausch & Lomb Surgical, Inc. on April 5, 2017 and is designated Class II. Reason for recall: Complaints concerning kinked haptics that were occurring during lens delivery. The recall status is terminated (terminated December 11, 2019).
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 5, 2017
- Termination Date
- December 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Distribution Pattern
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
Code Information
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.