STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milp

FDA device recall Z-1540-2013 · posted 2013-06-13 · Terminated

Recall details

Recalling firm

Abbott Medical Optics, Inc.

Reason for recall

Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

Action taken

AMO Manufacturing sent an Advisory Notice dated May 28, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the attached advisory notice to all affected customers in their assigned region. Customers were instructed to notify each surgeion at their site and complete and return the attached form to AMO via fax as an an acknowledgement of receipt of this advisory notice and that they understand the information contained within the letter. Customers with questions were instructed to contact their regional contact. For questions regarding this recall call 408-273-4016.

Root cause

Other

Status

Terminated

Product code

LZS

Quantity affected

1,882 - total all systems

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Ze

Date initiated

2013-05-28

Date posted

2013-06-13

Date terminated

2014-11-12

Location

Milpitas, CA