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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPort EasyLoad Lens Delivery System

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  Class 2 Device Recall SoftPort EasyLoad Lens Delivery System see related information
Date Initiated by Firm April 05, 2017
Create Date May 16, 2017
Recall Status1 Terminated 3 on December 11, 2019
Recall Number Z-2098-2017
Recall Event ID 77087
510(K)Number K970727  
Product Classification Folders and injectors, intraocular lens (iol) - Product Code MSS
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.
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.
Recalling Firm/
Bausch & Lomb Surgical, Inc.
21 N Park Place Blvd
Clearwater FL 33759-3917
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
Complaints concerning kinked haptics that were occurring during lens delivery.
FDA Determined
Cause 2
Device Design
Action Bausch & Lomb sent a Medical Device Recall letter dated April 18, 2017 to all their consignee informing them of the recall. Consignees were instructed to review their inventory and quarantine any unused product and return to Stericycle, the firm conducting this voluntary product recall on behalf of Bausch & Lomb. Contact Stericycle to arrange for a return at 1-877-469-8081. For replacement devices call 1-800-338-2020. Customers with questions were instructed to call 1-877-479-8081 or BauschandLomb5410@Stericycle.com. QUARANTINE PRODUCT AND RETURN TO BAUSCH + LOMB According to our records, your facility may have a supply of SofPort injection devices from the lots specified in this voluntary recall. We ask that you please quarantine any unused boxes (full and partial) and take the following steps to return the SofPort injection devices included in this voluntary recall to Stericycle, the firm conducting this voluntary product recall on behalf of Bausch + Lomb: 1. Please review your inventory and hold all unused (full and partial) boxes of SofPort injection devices. An example of the product label is provided below. 2. Complete the enclosed Medical Device Acknowledgement Form and return it to Stericycle. 3. Contact Stericycle to arrange for a return of the identified product in your facility at 1-877-479-8081. 4. Contact the Surgical Customer Service team to order replacement SofPort injection devices at 1-800- 338-2020. If you have questions or would like additional information, please call Stericycle, the firm conducting this voluntary recall on behalf of Bausch + Lomb, at 1-877-479-8081 or BauschandLomb5410@Stericycle.com.
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MSS and Original Applicant = CHIRON VISION CORP.