FDA Device Recall Z-0028-05: Ciba Vision Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-05.

Recall Res Number

Z-0028-05

Recalling Firm / Manufacturer

Ciba Vision Corporation

FEI Number

1053053

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-09-27

Date Posted

2004-10-21

Date Terminated

2005-08-22

Product Code

LPN

Event Number

30159

Product Quantity

5,913,120 units

Product Description SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.

Reason for Recall Stability tests at 24 months revealed failing results for disinfection efficacy.

Action Details Consignees were notified by letter on 10/01/2004.

Distribution Pattern Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia.

Code Information / Serial Numbers All sizes, configurations and all third part branded products

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Medical Device Recall: Z-0028-05

Recall Parameters & Description

Related Establishments / Registrations

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