inforMED
MalfunctionOJK

MEDLINE

Received Jun 2, 2026 · Event occurred May 1, 2026

Report 1423395-2026-00213 · MDR key 25366606

Device

Generic name

Cataract Pack

Catalog number

VAL0HDVCGSG

Lot number

26BBC267

Product problems

  • Leak/Splash

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT PVP LEAKED IN THE PACK.

Additional Manufacturer Narrative

IT WAS REPORTED THAT PVP LEAKED IN THE PACK. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.