MalfunctionHQF
PUREPOINT LASER
Received Jun 15, 2026
Report 2028159-2026-00861 · MDR key 25502759
Device
Generic name
Laser, Ophthalmic
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
NACatalog number
8065750597
Lot number
145R4H
Product problems
- Failure to Fire
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC LASER INDIRECT OPHTHALMOSCOPE POWER WAS LOW. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).