Abbott Medical Optics, Inc. Recalls
Showing 1-4 of 4 recalls
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Abbott Medical Optics (AMO) sent an Advisory Notice letter dated March 5, 2015 via FedEx overnight delivery to each Catalys Precision Laser System owner. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form. For questions contact AMO Technical Support at 1-855-662-0911.
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
The firm, Abbott Medical Optics, Inc., (AMO), sent an "ADVISORY NOTICE and a COVER LETTER FOR ADVISORY NOTICE" dated September 16, 2013 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the Star Notification Acknowledgement form via fax to 1-714-247-4530 within 3 business days or mail to Abbott Medical Optics, 510 Cottonwood Drive, MS 347118, Milpitas, CA 95035, and share this advisory notice with your staff. If you have any questions related to operation of STAR Excimer Laser System or documentation requirements associated with this letter, please call AMO Technical Support at 1-800-511-0911 and you will be directed to an AMO Representative.
STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
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.
Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery.
AMO issued an "Urgent Notice of Medical Device Correction and Advisory Notice" on May 23, 2013 via email, to all customers with a Sovereign Compact Phacoemulsification System v 5.3 to inform them of the issue and provide them with actions to take in the event of sound loss during use of the Sovereign Compact Phacoemulsification System, v 5.3.