Device product

Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.

Z-1554-2014

April 21, 2014

Class II

Product summary

Firm: Bausch & Lomb Inc- Greenville Solutions Plant
Event: Event 68095
Status: Terminated
Classification: Class II
Quantity: 256,440 bottles
Official record key: device-enforcement:Z-1554-2014

Official wording

Reason: Out of specification results for one of the two disinfectants.

Code information: 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.

Distribution pattern: US Nationwide.

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out of specification