Merilas
Meridian Medical d.o.o. · Model Merilas 532 alpha, Merilas 532 / 577 / 810 shortpulse · UDI-DI 03830074980048
Description
Merilas ophthalmic laser systems are solid-state, slit lamp-mounted devices designed for photocoagulation and other ophthalmic laser treatments. All models feature a compact design, air-cooled operation, and user-friendly interface with adjustable parameters for power, pulse duration, and repetition rate. Each system includes a slit lamp adapter, aiming beam, and ergonomic controls for precise treatment delivery. The product family includes four wavelength-specific models: Merilas 532 alpha: Continuous-wave laser emitting at 532 nm, used for retinal photocoagulation procedures such as panretinal and focal treatments. Merilas 532 shortpulse: Short-pulse laser at 532 nm, designed for subthreshold retinal therapy to reduce thermal damage while maintaining therapeutic effect. Merilas 577 shortpulse: Short-pulse laser at 577 nm, optimized for treating macular edema and central serous retinopathy with reduced light scattering and selective absorption. Merilas 810 shortpulse: Infrared short-pulse laser at 810 nm, intended for transscleral cyclophotocoagulation and other glaucoma-related procedures requiring deeper tissue penetration. All Merilas systems are compliant with IEC 60601-1, EN 60601-1-2, and applicable medical device directives. They are intended for use by trained ophthalmic professionals in clinical environments.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-05 | Beaver-Visitec International, Inc. | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. Th |
| 2023-03-16 | Ellex Medical Pty Ltd. | When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output |
| 2021-04-14 | Dutch Ophthalmic USA, Inc. | Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01 |
| 2016-07-15 | Topcon Medical Laser Systems, Inc | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) fu |
| 2016-02-01 | Laserex Systems Inc. | The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented. |
| 2014-12-18 | Ziemer Usa Inc | The devices were not shipped with the Starter Kits. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-11-04 | Bausch & Lomb Inc | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| 2014-08-15 | Lumenis, Inc. | 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 |
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