Z-2098-2017Class II

SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO...

Name: Z-2098-2017 SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO...
Creator: Bausch & Lomb Surgical, Inc.
Published: 2017-04-05
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2017-04-05 / Terminated / root cause: design

FDA source

Bausch & Lomb Surgical, Inc. began a recall of 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... on 2017-04-05. FDA classified it as Class II and gives the reason as "Complaints concerning kinked haptics that were occurring during lens delivery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2098-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-05
Posted: 2017-05-16
Terminated: 2019-12-11
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: MSS Folders And Injectors, Intraocular Lens (Iol)
Reason for recall: Complaints concerning kinked haptics that were occurring during lens delivery.
Root cause tag: design
FDA 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 [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].
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2098-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2098-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-16

Product code MSS

K970727Class IMport Foldable Lens Placement SystemChiron Vision Corp. / cleared 1997-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)