MalfunctionHQF
PUREPOINT LASER
Received Jun 22, 2026 · Event occurred May 27, 2026
Report 2028159-2026-00895 · MDR key 25573922
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
NA · 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 CONSOLE EXHIBITS THE LASER SHOT PROBLEM. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN REPORTED.