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U.S. Department of Health and Human Services

Class 2 Device Recall Next Generation Laser

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  Class 2 Device Recall Next Generation Laser see related information
Date Initiated by Firm September 26, 2008
Date Posted November 06, 2008
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-0274-2009
Recall Event ID 49600
Product Classification Ophthalmic Laser - Product Code HQF
Product PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597

Indicated for use in photocoagulation of both anterior and posterior segments of the eye.
Code Information Serial Numbers 0801438901X, 0801481701X2, 0801591601X2, 0801591701X1, 0801591801X1, 0801692701X1, 0801717801X3, 0801717901X, 0801718001X1, 0801718101X, 0801718201X, 0801763401X1, 0801763601X, 0801817201X, 0801817601X, 0801844601X1, 0801844701X1, 0801844801X1, 0801844901X, 0801845001X1, 0801887201X, 0801887501X, 0801887601X, 0801965801X, 0801965901X, 0801966001X, 0802057301X, 0802057501X, 0802244501X, 0802244701X, 0802245101X, 0802480501X, 0802480901X, 0802484101X, 0802514101X, 0802529501X, 0802570101X, 0801887401X, 0802244301X, 0801439201X, and 0802244901X, 
Recalling Firm/
Manufacturer		 Alcon Laboratories, Inc.
15800 Alton Pkwy
Irvine CA 92618
For Additional Information Contact
949-753-1393
Manufacturer Reason
for Recall		 Alcon had identified that indications for use unapproved by the Food and Drug Administration are included in the PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Revision B.
FDA Determined
Cause 2		 Employee error
Action An Alcon representative has been provided with a package of information for each customer site. All domestic customers are being provided an Urgent: Medical Device Correction letter describing the change to the PurePoint Operator's Manual and are being issued a revised PurePoint Operator's Manual (Revision C). The letter advises that Alcon Research, Ltd, has initiated a voluntary correction based upon unapproved indications for use identified within the Alcon PurePoint Laser System Operator's Manual, Revision B. The letter advises that the following indications for use have been updated or removed on page 1.14, Professional Operator's Information, in Revision C of the PurePoint Laser System Operator's Manual: Updated: "AMD; Wet or Dry to include macular degeneration" has been updated to read "Choroidal neovascularization secondary to age-related macular degeneration (AMD)". "Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG), Acute Angle Closure Glaucoma (AACG), and refractory glaucoma" has been updated to read "Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG) and refractory glaucoma" Removed: Macular photocoagulation; including grid, focal, laser drusen scatter (panretinal) Transcleral cyclophotocoagulation Intra-ocular tumors; to include choroidal hemangioma, choroidal melanoma, retinoblastoma Otosclerotic hearing loss. No other changes to the manual have been made in this revision and no other Alcon products are affected by this correction. Per the letter, an Alcon Representative will provide customers with a new PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev. C. and customers are return their existing PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev.B. A signed confirmation of receipt of the letter is required from all customers.
Quantity in Commerce 41 units
Distribution Worldwide Distribution --- USA including states of IL, WI, TX, MI, PA, NY, CT, SC, NC, LA, FL, GA, CA, OR, WA, CO, and NV, and countries of India, Bulgaria, Barbados, and Dominican Republic.
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.
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