Carl Zeiss Meditec recalls laser device

August 1, 2004

Dublin, CA-Defective coating on a mirror on the Carl Zeiss Meditec's VISULINK 532/U instrument is prompting the recall of three affected units.

Dublin, CA-Defective coating on a mirror on the Carl Zeiss Meditec's VISULINK 532/U instrument is prompting the recall of three affected units.

The device, used with the VISULAS 532s laser, featured a coating on the reflective mirror that could tear and loosen from the mirror surface. The damaged mirror could then misdirect the laser beam to an unintended target in or on the eye, causing retinal bleeding or burns, according to the FDA.

Carl Zeiss Meditec said it had sold three of the six affected units it had imported for use within the United States. Once it became aware that the coating could loosen, the company notified the customers on June 3, warned them to stop using the units immediately, and removed the units for repair.