Reported May 24, 2017 · Terminated

SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or…

Bausch & Lomb Surgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bausch & Lomb Surgical, Inc. · 21 N Park Place Blvd · Clearwater, FL · 33759-3917

Is this the product you have?

  • SoftPort
  • Easy-Load Lens Delivery System ModelEZ-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
Lot codes and dates

9 of 9 products

Products covered by this recall
#Product as published
1Lot Number: H671901 Expiration Date: Dec-17
2Lot Number: H672001 Expiration Date: Nov-17
3Lot Number: H672602 Expiration Date: Dec-17
4Lot Number: H674001 Expiration Date: Dec-17
5Lot Number: H674401 Expiration Date: Nov-17
6Lot Number: H674801 Expiration Date: Dec-17
7Lot Number: H675401 Expiration Date: Dec-17
8Lot Number: H740301 Expiration Date: Dec-17, and
9Lot Number: H743201 Expiration Date: Feb-18.

Where it was sold

Why it was recalled

Complaints concerning kinked haptics that were occurring during lens delivery.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 11, 2019 · Data as of Sep 19, 6:07 PM UTC

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