Home › Carl Zeiss Meditec AG › MEL 90

MEL 90

Carl Zeiss Meditec AG · Model 1900-109 · UDI-DI 04049471095074

LZS Prescription

510(k) clearances

13,742

Adverse events (12 deaths)

Recalls

Facilities

Description

The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter. Indications for Use: The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of: • Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D; • Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and • Mixed astigmatism with cylinder from >1.00 D up to 4.00 D; in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.

Recalls

Date	Firm	Reason
2021-10-21	AMO Manufacturing USA, LLC	Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly p
2017-02-01	Nidek Inc	During treatment planning, the procedure was programmed with an unintended (wrong) correction.
2015-03-24	Nidek Inc	Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
2013-09-16	Abbott Medical Optics, Inc.	This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the
2013-09-16	Abbott Medical Optics, Inc.	This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the
2013-09-16	Abbott Medical Optics, Inc.	This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the
2013-09-16	Abbott Medical Optics, Inc.	This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the
2013-05-28	Abbott Medical Optics, Inc.	Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
2013-05-28	Abbott Medical Optics, Inc.	Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
2013-05-28	Abbott Medical Optics, Inc.	Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.