AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051

FDA device recall Z-1139-2008 · posted 2008-06-05 · Terminated

Recall details

Recalling firm

VISX INCORPORATED, A SUBSIDIARY OF AMO INC

Reason for recall

Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.

Action taken

On December 13, 2007, firm issued an Urgent Safety Notice to all VISX and IntraLase laser owners related to recall. The Safety Notice contains information related to the measures that can be taken to prevent unintentional movement of any chair during other procedures. AMO is initiating a field corrective action, whereby Field Service Engineers will visit each practice that owns both systems to disable the VISX chair back switch. For additional information, please contact AMO at (714) 247-8656.

Root cause

Component design/selection

Status

Terminated

Product code

LZS

Quantity affected

1,853 units

Distribution

Worldwide Distribution - USA, including the states of: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA W

Date initiated

2007-12-13

Date posted

2008-06-05

Date terminated

2010-05-05

Location

Santa Clara, CA