Home › Device types › HQF
Laser, Ophthalmic
FDA product code HQF · Class 2 · Ophthalmic
2,127
Registered devices
1,534
Adverse events
32
Recalls
180
510(k) clearances
Devices with this code
ASSEMBLY, FOOTSWITCH IQ SERIES — IRIDEX CORPORATIONNA — OPHTHALMED LLCNA — OPHTHALMED LLCLIO Plus (532 nm & 810 nm) — IRIDEX CORPORATIONLightlas SeLecTor Deux — LIGHTMED CORPORATIONNA — OPHTHALMED LLCStepped Laser probe, 25 gauge / 0,5mm with Alcon® connector — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NA — OPHTHALMED LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLCVitreQ — Vitreq B.V.27ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Quantel — KATALYST SURGICAL LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLCDirectional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Illuminated Laser Probe, Curved, 20G / 0.9 mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NA — OPHTHALMED LLC25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector — KATALYST SURGICAL LLCNA — OPHTHALMED LLC25ga Straight Laser Probe, Quantel — KATALYST SURGICAL LLCVitreQ — Vitreq B.V.NA — OPHTHALMED LLC20ga Curved Illuminated Laser Probe, 19ga Needle Illumination, Iridex — KATALYST SURGICAL LLCMerilas — Meridian Medical d.o.o.
Recent 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 insta |
| 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 |
| 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- |
| 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 t |
| 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 |
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