FDA Device recall Z-2098-2017

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…

FDA Device
Class II
terminated
Published 2017-05-24

On 2017-05-24 the FDA classified a Class II 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… by Bausch And Lomb Surgical, citing complaints concerning kinked haptics that were occurring during lens delivery.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2098-2017
Classification	Class II
Status	terminated
Initiated	2017-04-05
Published	2017-05-24
Last updated	2026-09-13 11:54 UTC
Company	Bausch And Lomb Surgical
Distribution	US

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.

Reason

Complaints concerning kinked haptics that were occurring during lens delivery.

Identifiers

code_info	Lot Number: H671901 Expiration Date: Dec-17, Lot Number: H672001 Expiration Date: Nov-17, Lot Number: H672602 Exp… 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.

code_info

Lot Number: H671901 Expiration Date: Dec-17, Lot Number: H672001 Expiration Date: Nov-17, Lot Number: H672602 Exp…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2098-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.