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

Premarket Approval (PMA)
  • 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
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP990014
Date Received03/04/1999
Decision Date11/12/1999
Withdrawal Date 10/11/2023
Product Code HQL 
Docket Number 99M-5135
Notice Date 12/10/1999
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
This device is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed by extracapsular extraction methods. The lens is intended for placement in the capsular bag.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 
-
-