• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Domilens

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Domilenssee related information
Date Initiated by FirmOctober 08, 2003
Date PostedNovember 13, 2003
Recall Status1 Terminated 3 on August 09, 2004
Recall NumberZ-0111-04
Recall Event ID 27457
PMA NumberP810025 
Product Classification Aid, Surgical, Viscoelastic - Product Code LZP
ProductDomiVisc Sodium Hyaluronate 0.8 mL 12 mg.mL Syringe. Sterile.RX. For intraocular use Product Numbner; P012-180A Manufactured for Bausch & Lomb
Code Information Lot Numbers: B020122A, B020122J
Recalling Firm/
Manufacturer
Anika Therapeutics
240 West Cummings Park
Woburn MA 01801
For Additional Information ContactJulie Broderick
781-932-6616 Ext. 107
Manufacturer Reason
for Recall
Stability failure at the 20 month for viscosity specification
FDA Determined
Cause 2
Other
ActionAnika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
Quantity in Commerce 4948 units
DistributionCA, MO, NC,VA
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LZP
-
-