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.
FDA Recall Z-2098-2017 · Posted None
Recalling FirmBausch & Lomb Surgical, Inc.
Recall StatusTerminated
Product CodeMSS
Date Initiated2017-04-05
Date Terminated2019-12-11
Reason for Recall
Complaints concerning kinked haptics that were occurring during lens delivery.
Firm 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 [email protected].
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 [email protected].
Root Cause
Device Design
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.