Home › Device types › HQF
Laser, Ophthalmic
FDA product code HQF · Class 2 · Ophthalmic
2,127
Registered devices
1,525
Adverse events
32
Recalls
180
510(k) clearances
Devices with this code
NA — OPHTHALMED LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLCScan attachable delivery unit (30SL/M) — NIDEK CO.,LTD.Solitaire — ELLEX MEDICAL PTY LTDNA — OPHTHALMED LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLCSlit lamp delivery unit (SL-1800) — NIDEK CO.,LTD.25ga Inverted Extendable MultiFlex Laser Probe, Dorc Connector — KATALYST SURGICAL LLCEllex — ELLEX MEDICAL PTY LTDNA — OPHTHALMED LLC20GA Straight Laser Probe, SMA906 — Peregrine Surgical, LlcNA — OPHTHALMED LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLCACC. PROBE, ENDO. STRAIGHT,25G — ELLEX MEDICAL PTY LTDNA — OPHTHALMED LLCXLEND23MULTIFLEX — KATALYST SURGICAL LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLCNA — OPHTHALMED LLC
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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