Recall Z-2733-2014 ยท HQF Laser, Ophthalmic
Lumenis, Inc.
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Sever
| Date | Sep 30, 2014 (initiated Aug 15, 2014) |
| Status | Terminated |
| Reason | Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern. |
| Root cause | Software design |
| Action | Lumenis sent a Safety Advisory Notice dated July 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that Lumenis would contact consignees to schedule a product update, to be completed at a convenient time. For questions consignees should call 801-656-2549. For questions regarding this recall call 801-656-2690. |
| Quantity | 16 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130195 | SCANNING LASERLINK Lumenis, Inc., Nov 1, 2013 |