Bausch & Lomb Surgical, Inc.: 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.

Recall number

Z-2098-2017

Recalling firm

Bausch & Lomb Surgical, Inc.

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.

Status

Terminated

Initiated

2017-04-05

Posted

not on file

Terminated

2019-12-11

Reason

Complaints concerning kinked haptics that were occurring during lens delivery.

Root cause

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.

Quantity

not on file

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

Lot, serial or model codes

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.

510(k) numbers

["K970727"]

PMA numbers

not on file

Product code

MSS

Firm FEI

1119279

Firm city

Clearwater

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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