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

Class 2 Device Recall Sensar Foldable IOL with OptiEdge

  • 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 Sensar Foldable IOL with OptiEdge see related information
Date Posted March 09, 2013
Recall Status1 Terminated on January 08, 2014
Recall Number Z-0929-2013
Recall Event ID 64015
PMA Number P980040 
Product Classification intraocular lens - Product Code HQL
Product AMO Sensar Intraocular Lenses (IOLs), Model AR40e,
Sensar Foldable IOL with OptiEdge

Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Code Information Diopter 18.0
4760271207 4760661207 4761191207
4760281207 4760681207 4761211207
4760291207 4760701207 4761221207
4760301207 4760721207 4761231207
4760311207 4760741207 4761241207
4760321207 4760761207 4761251207
4760331207 4760781207 4761261207
4760341207 4760801207 4761271207
4760351207 4760811207 4761281207
4760361207 4760821207
4760371207 4760841207
4760381207 4760861207
4760391207 4760881207
4760401207 4760901207
4760411207 4760921207
4760421207 4760941207
4760431207 4760961207
4760441207 4760981207
4760451207 4761001207
4760461207 4761031207
4760471207 4761041207
4760481207 4761051207
4760491207 4761061207
4760501207 4761071207
4760511207 4761081207
4760531207 4761091207
4760551207 4761101207
4760571207 4761111207
4760591207 4761121207
4760601207 4761131207
4760611207 4761151207
4760621207 4761161207
4760631207 4761171207
4760641207 4761181207

Diopter 23.5
4759221207 4759821207 4760161207
4759231207 4759831207 4760171207
4759241207 4759841207 4760181207
4759251207 4759851207 4760191207
4759261207 4759861207 4760201207
4759271207 4759871207 4760211207
4759281207 4759881207 4760221207
4759291207 4759891207 4760231207
4759311207 4759901207 4760241207
4759321207 4759911207 4760251207
4759331207 4759921207
4759341207 4759931207
4759361207 4759941207
4759381207 4759951207
4759401207 4759961207
4759421207 4759971207
4759441207 4759981207
4759461207 4759991207
4759481207 4760001207
4759671207 4760011207
4759681207 4760021207
4759691207 4760031207
4759701207 4760041207
4759711207 4760051207
4759721207 4760061207
4759731207 4760071207
4759741207 4760081207
4759751207 4760091207
4759761207 4760101207
4759771207 4760111207
4759781207 4760121207
4759791207 4760131207
4759801207 4760141207
4759811207 4760151207
Recalling Firm/
Manufacturer
Abbott Medical Optics Inc (AMO)
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact
714-247-8656
Manufacturer Reason
for Recall
Two production orders of these IOLs that contain mislabeled IOLs.
FDA Determined
Cause 2
Process control
Action AMO sent an Urgent Field Safety Notice letter to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to stop using and remove affected product from inventory. The letter advice customers to complete and return the enclosed Facsimile Form. For questions contact AMO Customer Service Representative.
Quantity in Commerce 155 units
Distribution Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = HQL and Original Applicant = ABBOTT MEDICAL OPTICS INC
-
-