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Terminated

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.

FDA Recall Z-0166-2012 · Posted 2011-11-04

Recalling FirmAMO Manufacturing USA, LLC
Recall StatusTerminated
Product CodeHNO
Date Initiated2011-10-12
Date Terminated2013-05-01
Product Quantity1226 total laser systems

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.

Firm 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

Root Cause

Process design

Distribution Pattern

Worldwide Distribution - USA (nationwide)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031960INTRALASE FS LASERIntra Lase Corp. · 2003-09-29

Official Source

View FDA Recall →

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

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