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Medical Device Recalls
Class 2 Recall
Next Generation Laser
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Date Recall
Initiated |
September 26, 2008
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| Date Posted |
November 06, 2008
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| Recall Number |
Z-0274-2009
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| 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.
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| 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,
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Recalling Firm/
Manufacturer |
Alcon Laboratories, Inc.
15800 Alton Pkwy
Irvine
, California
92618
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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.
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| 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.
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| Quantity in Commerce |
41 units
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| 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.
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