SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the… — Class II medical device recall Z-2098-2017
Terminated recall by Bausch & Lomb Surgical, Inc., reported 2017-05-24, distributed nationwide. Complaints concerning kinked haptics that were occurring during lens delivery.
| Recall number | Z-2098-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Surgical, Inc., Clearwater, FL, United States |
| Recall initiated | 2017-04-05 |
| Classified | 2017-05-16 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2019-12-11 |
| Distributed | Nationwide (US) |
| Lot numbers | DEC-17, FEB-18, H671901, H672001, H672602, H674001, H674401, H674801, H675401, H740301, H743201, NOV-17 |
| Model numbers | EZ-28V |
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 for recall
Complaints concerning kinked haptics that were occurring during lens delivery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2098-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.