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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Bausch And Lomb Surgical
- Akreos, SKU: AO60P0300
FDA Device · Class III · 2025-09-03 · Bausch And Lomb Surgical - Intraocular Lens. enVista Envy IOL, All models starting with EN
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical - Intraocular lens. enVista Monofocal IOL, All models starting with EE
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical - MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placeme…
FDA Device · Class II · 2020-12-09 · Bausch And Lomb Surgical - enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the…
FDA Device · Class II · 2020-07-22 · Bausch And Lomb Surgical
All Bausch And Lomb Surgical recalls
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.