MalfunctionHQF
PUREPOINT LASER
Received Jun 5, 2026
Report 2028159-2026-00800 · MDR key 25404988
Device
Generic name
Laser, Ophthalmic
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
NACatalog number
8065750597
Lot number
NA
Product problems
- Failure to Fire
Patient
Unknown
- Insufficient Information
Narrative
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).
Description of Event or Problem
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER INDIRECT OPHTHALMOSCOPE (LIO) EXHIBITED LOW POWER OUTPUT. DETAILS RELATED TO PATIENT HARM HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.