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 TECNIS

  • 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 TECNIS see related information
Date Initiated by Firm August 26, 2016
Date Posted September 21, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall Number Z-2863-2016
Recall Event ID 75051
PMA Number P980040 
Product Classification intraocular lens - Product Code HQL
Product TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00
The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag
Code Information Serial No. 8213991504 8214001504 8214011504 8214021504 8214031504 8214041504 8214051504 8214061504 8214071504 8214101504 8538801603 8538821603 8538831603 8538841603 8538871603 8538891603 8538901603 8538971603 8538981603 8416821507 8416831507 8416841507 8416851507     8416911507 8416921507 8416951507 8416961507 8416971507 8416991507 8417001507 8417011507 8417021507 8417041507 8417071507 8417081507 8417091507 8417101507 8445191507 8505901605 8505911605 8505961605 
Recalling Firm/
Manufacturer		 Abbott Medical Optics Inc. (AMO)
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact
714-247-8200
Manufacturer Reason
for Recall		 Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
FDA Determined
Cause 2		 Process control
Action Abbott Medical Optics, Inc. sent an Urgent Field Safety Notice to all affected customers to inform them that Abbott Medical Optics (AMO) is recalling 737 IOLs due to detection of an inspection equipment malfunction that resulted in a total of 737 distributed lenses not being fully checked prior to release. The letter informs customers that this malfunction may result in the release of mislabeled IOLs. The letter informs the customers of the actions to be taken. Customers are instructed to complete Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com. Customers with any questions related to the IOL return process are instructed to contact an AMO Customer Service Representative at 877-266-4543. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543.
Quantity in Commerce 41 units
Distribution Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
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.
PMA Database PMAs with Product Code = HQL and Original Applicant = Johnson & Johnson Surgical Vision, Inc.
-
-