Recall Z-0274-2009 ยท HQF Laser, Ophthalmic
Alcon Laboratories, Inc.
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.
| Date | Nov 6, 2008 (initiated Sep 26, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.