MalfunctionHQB
ALCON, ENGAUGE
Received Mar 19, 2025 · Event occurred Oct 1, 2024
Report 21641834 · MDR key 21641834
Device
Generic name
Photocoagulator And Accessories
Manufacturer
Alcon Laboratories, Inc.Model number
8065751593Catalog number
8065751593
Lot number
16VCK1
Patient
51 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE HAVE HAD FOUR LASER CONSTELLATIONS SENT TO US WHERE THE RFID [RADIO FREQUENCY IDENTIFICATION] WAS NOT PROGRAMMED. THIS CAUSED THE MACHINE TO NOT RECOGNIZE THE LASERS. MFG STATES THIS IS A MANUFACTURING ERROR. MANUFACTURER RESPONSE FOR LASER CONSTELLATION 25GA ILLUMINATED FLEX PROBE, (BRAND NOT PROVIDED) (PER SITE REPORTER). MFG STATES THIS IS A MANUFACTURING ERROR.