CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, Sterile recalled
Bausch & Lomb Inc- Greenville Solutions Plant is recalling Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, Sterile, distributed nationwide in the US. The recall was initiated on 21 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1554-2014
- FDA event ID
- 68095
- Recalling firm
- Bausch & Lomb Inc- Greenville Solutions Plant, Greenville, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Apr 2014
- FDA classified
- 6 May 2014
- Reported
- 14 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Contact Lenses & Eye Devices
Timeline
| 21 Apr 2014 | Recall initiated by company | |
| 6 May 2014 | Classified by FDA | +15 days |
| 14 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of specification results for one of the two disinfectants.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Where it was distributed
US Nationwide.
Questions about this recall
Is Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, Sterile recalled?
Yes. Bausch & Lomb Inc- Greenville Solutions Plant recalled Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, Sterile on 21 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1554-2014.
Why was it recalled?
Out of specification results for one of the two disinfectants.
Which lots are affected?
Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.
Where was it sold?
US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bausch & Lomb Inc- Greenville Solutions Plant
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Equate Moisture Last Multi-Purpose Solution recalled | Bausch & Lomb Inc- Greenville Solutions Plant | Other | Nationwide |
Other Contact Lenses & Eye Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |