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U.S. Department of Health and Human Services

Class 2 Device Recall INTRALASE FS Laser

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  Class 2 Device Recall INTRALASE FS Laser see related information
Date Initiated by Firm October 12, 2011
Date Posted November 04, 2011
Recall Status1 Terminated 3 on May 01, 2013
Recall Number Z-0166-2012
Recall Event ID 60241
510(K)Number K031960  
Product Classification Keratome, ac-powered - Product Code HNO
Product Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA

Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
Code Information All units of these models (models 2, 3 and iFS) except model 1.
Recalling Firm/
AMO Manufacturing USA, LLC
510 Cottonwood Dr
Milpitas CA 95035-7403
For Additional Information Contact
Manufacturer Reason
for Recall
The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 ¿m or deeper) created using the Laser System.
FDA Determined
Cause 2
Process design
Action Abbott Medical Optics Inc. (AMO) issued an "ADVISORY NOTICE" letter dated October 12, 2011 to all affected customers. The letter identifies the affected products, the problem, and the actions needed to be taken. Customers were instructed to exercise caution when making cuts that approach the corneal endothelium. The letter includes a 1-page Operator's Manual addendum that clarifies the recommendations. The letter states that AMO will conduct a field correction to adjust the EOF on the affected FS Laser Systems. The letter includes a response form to be completed and returned as per the instructions. Customers were instructed to notify all appropriate staff/personnel of the Advisory Notice. For any further questions regarding the information or recommendations, contact an AMO representative at 1-800-266-3375
Quantity in Commerce 1226 total laser systems
Distribution Worldwide Distribution - USA (nationwide)
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HNO and Original Applicant = INTRALASE CORP.