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Zeiss voluntarily recalled laser accessory device
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DUBLIN, Calif. — Laser manufacturer Carl Zeiss Meditec voluntarily recalled one lot of a device used with its Visulas 532s laser because of the possibility the devices might contain a defective mirror coating, the company announced.
According to a spokeswoman for Carl Zeiss Meditec, the ad hoc, voluntary recall involved “exactly 20 Visulink 532/U units worldwide.” This included three units that were commercially distributed in the United States, according to a press release from the company.
According to the company, the Visulink is used in conjunction with the Visulas 532s laser, which is designed for photocoagulation of ocular tissues. The Visulink is a device used to mount the laser on diagnostic slit lamps, according to information on the Zeiss Web site.
“There is now no further risk for our customers or their patients with the Visulink 532/U or the Visulas 532s laser,” the Zeiss spokeswoman said. She added that no other lots of the Visulink device, no Visulas lasers and no other Carl Zeiss Meditec devices were involved in the recall.
The coating of the reflecting mirror in the affected lot of the Visulink 532/U could potentially loosen from the surface, according to the press release. The mirror routes the treatment beam to the patient’s eye, and malfunction could have caused the laser beam to permanently damage the retina, the company said.
Six affected units were imported for distribution in the United States, and of those three were introduced into commercial distribution. Carl Zeiss Meditec notified its customers on June 3 to stop using the units and removed all the units for repair, according to the press release.
The Food and Drug Administration considered this malfunction a Class 1 recall. No reports of injury were associated with the product, according to the press release.