To Withdraw FDA Approval (PMA) for all LASIK Devices and Issue a Public Health Advisory with a Voluntary Recall of LASIK Devices in an Effort to Stop the Epidemic of Permanent eye Injury Caused by Lasers and Microkeratomes used for LASIK eye Surgery

 
Docket ID: FDA-2011-P-0022
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: To Withdraw FDA Approval (PMA) for all LASIK Devices and Issue a Public Health Advisory with a Voluntary Recall of LASIK Devices in an Effort to Stop the Epidemic of Permanent eye Injury
Keyword(s): cdrh, LASIK, eye surgery, micokeratomes, open
Type: Nonrulemaking
Docket Status: OPEN
Center: CDRH
Docket Item Code: P
 

Primary Documents

View All  (9)
Comment Period Closed
Other
Posted: 01/26/2015
ID: FDA-2011-P-0022-0011
Other
Posted: 09/04/2014
ID: FDA-2011-P-0022-0009
Comment Period Closed
Other
Posted: 09/04/2014
ID: FDA-2011-P-0022-0010
Comment Period Closed
Other
Posted: 08/15/2014
ID: FDA-2011-P-0022-0008
Comments Not Accepted
Other
Posted: 08/14/2012
ID: FDA-2011-P-0022-0006

Supporting Documents

View All  (2)
Comments Not Accepted
Supporting & Related Material
Posted: 05/26/2015
ID: FDA-2011-P-0022-0012
Comments Not Accepted
Supporting & Related Material
Posted: 08/15/2012
ID: FDA-2011-P-0022-0007

Comments

View All  (1)

6
Comments Received*
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.