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Terminated

Intralase FS Laser System. Laser Keratome

FDA Recall Z-1124-03 · Posted 2003-08-12

Recalling FirmIntralase Corp
Recall StatusTerminated
Product CodeGEX
Date Initiated2003-07-15
Date Terminated2004-12-02
Product Quantity70

Reason for Recall

Gantry moves toward patient when 'Home' button is used after procedure.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013941PULSION FS LASER KERATOMEIntra Lase Corp. · 2002-02-27K002890INTRALASE 600C LASER KERATOMEIntra Lase Corp. · 2001-08-09K001211MODIFICATION TO INTRALASE 600C LASER KERATOMEIntra Lase Corp. · 2000-12-04K993153INTRALASE 600C LASER KERATOMEIntra Lase Corp. · 1999-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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