List of FDA warning letters to LASIK clinics

Latest FDA Warning Letters

10/27/2009

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking the link following each company name.

Lasik Vision Institute
Carmel, IN
(10/9) Misbranded: FDA determined that the facility is a medical device user facility that is subject to the statutory reporting requirements of the Medical Device Reporting (MDR) regulation. The facility failed to develop, maintain, and implement written MDR procedures, etc. (ophthalmic laser); FDCA 502(1)(2), 519, 21 CFR 803 (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187553.htm

Lasik Vision Institute
Altamonte Springs, FL
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187563.htm

Lasik Vision Institute
Brookfield, WI
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187557.htm

LCA Vision Inc. [LasikPlus]
Rockville, MD
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187574.htm

LCA Vision Inc. dba LasikPlus
Maple Grove, MN
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187584.htm

LasikPlus Vision Center
Chicago, IL
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187544.htm

LCA Vision Inc. dba LasikPlus
Edina, MN
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187604.htm

TLC Laser Eye Centers
Rockville, MD
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187542.htm

LasikPlus Vision Center
Lakewood, CO
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187568.htm

LasikPlus Vision Center
Raleigh, NC
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187550.htm

LasikPlus Vision Center
Indianapolis, IN
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187564.htm

Lasik Vision Institute
Phoenix, AZ
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187551.htm

LasikPlus Vision Center
Louisville, KY
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187543.htm

Laser Eye Care of California
Encino, CA
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187554.htm

TLC Laser Eye Centers
Edgewater, MD
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187543.htm

TLC Laser Eye Centers
McLean, VA
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187549.htm

TLC Laser Eye Center
Sewickley, PA
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm187555.htm

TLC Eye Care
Lansing, Michigan
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192369.htm

Lasik Plus
Houston, Texas
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192704.htm

LCA Vision Inc
Lexington, Kentucky
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192705.htm

LasikPlusVision Center
Sugar Land, Texas
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm197273.htm