Green Laser Photocoagulator GYC-500Recalls & reported problems
Nidek CO.,Ltd. · The NIDEK Green Laser Photocoagulator GYC-500 is a laser photocoagulator for ophthalmology using a 532 nm diode-pumped solid-state laser (green laser beam) as the treatment beam source. The device incorporates a diode-pumped laser that enables efficient laser beam emission at 532 nm. For the laser beam delivery, various types of delivery units may be employed. This allows performance of transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987669100851), received between May 31, 2018 and May 31, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component or Accessory Incompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Component or Accessory Incompatibility1
- Device Operates Differently Than Expected1
Patient problems
- Flashers1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2018Component or Accessory Incompatibility; Device Operates Differently Than Expected; Component or Accessory Incompatibility; Device Operates Differently Than Expected
NIDEK INC. RECEIVED A COMPLAINT FROM OUR TERRITORY SALES MANAGER ON (B)(6) 2018 THAT THE CUSTOMER (RETINA SPECIALIST) WAS EXPERIENCING INTENSE FLASHBACK DURING LASER FIRING. THE DOCTOR WAS PERFORMING PRP (PANRETINAL PHOTOCOAGULATION) ON A PATIENT USING GYC-500D VIA SL 1800 AND A NEW LASER LENS. THE DOCTOR REPORTED OF BEING UNABLE TO EFFECTIVELY TREAT THE PATIENT IN SPITE OF A CLEAR VIEW/FOCUS USING 200NM SPOT SIZE / POWER 1200MW AT .10 SEC EXPOSURE EVERY .20 SECONDS HOLDING PEDAL DOWN. THE EPISODE OF FLASHING LASTED THROUGHT THE DURATION OF THE LASER PULSE. NO INJURY WAS REPORTED THAT TIME AND HENCE NO PATIENT INFORMATION IS AVAILABLE.
Patient problems: Flashers; No Known Impact Or Consequence To Patient
MAUDE report 7558683 ↗
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- Alcon, Engauge 8065751709Alcon Laboratories, Inc. · Laser, ophthalmic14 reports
- Alcon, Engauge 8065750991Alcon Laboratories, Inc. · Laser, ophthalmic10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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