PUREPOINT LASER
Received Jun 18, 2026 · Event occurred May 25, 2026
Report 2028159-2026-00878 · MDR key 25544343
Device
Generic name
Laser, Ophthalmic
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
NACatalog number
8065750597
Lot number
NA
Product problems
- Failure to Fire
- Incomplete or Inadequate Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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, BEFORE SURGERY AN OPHTHALMIC OPERATING SYSTEM DELIVERED LOW LASER POWER AND CHALLENGES WERE ENCOUNTERED IN BOTH INSERTING AND REMOVING THE OPHTHALMIC PROBE FROM THE SYSTEM PORT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER SYSTEM, AND THERE WAS NO PATIENT HARM.