MalfunctionOJK
MEDLINE
Received Jun 2, 2026 · Event occurred May 1, 2026
Report 1423395-2026-00213 · MDR key 25366606
Device
Generic name
Cataract Pack
Manufacturer
Medline Industries, Lp - SptCatalog 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.