Intralase FS Laser System. Laser Keratome Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Intralase FS Laser System. Laser Keratome
Lot Codes / Batch Numbers
All codes
Products Sold
All codes
A medical device manufacturer is recalling Intralase FS Laser System. Laser Keratome due to Gantry moves toward patient when 'Home' button is used after procedure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Gantry moves toward patient when 'Home' button is used after procedure.
Recommended Action
Per FDA guidance
Firm sent Safety Alert letters to customers on July 15, 2003 by registered mail instructing not to use the HOME button, including a 'Do Not Use' sticker for the machine and an addendum to the Operations Manual.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026