Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112

  • 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 2 Device Recall Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112 see related information
Date Initiated by Firm July 27, 2011
Date Posted August 30, 2011
Recall Status1 Terminated 3 on June 21, 2013
Recall Number Z-3089-2011
Recall Event ID 59662
510(K)Number K082473  
Product Classification Phacofragmentationn Unit - Product Code HQC
Product Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY

For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery
Code Information Model # BL5112, Lot #U6476,  Exp. 11/2012
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Joseph Tsai
949-521-7895
Manufacturer Reason
for Recall		 The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.
Quantity in Commerce 2/6-unit cases
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = BAUSCH & LOMB, INC.
-
-