Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1139-2008 · Posted 2008-06-05

Recalling FirmVISX INCORPORATED, A SUBSIDIARY OF AMO INC
Recall StatusTerminated
Product CodeLZS
Date Initiated2007-12-13
Date Terminated2010-05-05
Product Quantity1,853 units

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.

Firm Action

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

Distribution Pattern

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 WI WV and countries of: Argentina Australia Austria Bahrain Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Cyprus Czech Republic Djibouti Dominican Rep. Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kasachstan Kuwait Lebanon Malaysia Martinique Mexico Mongolia Netherlands New Zealand Norway Oman Pakistan Paraguay Philippines Poland Portugal Russian Fed. Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Trinidad,Tobago Turkey Unit.Arab Emir. Venezuela Vietnam

Official Source

View FDA Recall →

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

↑