MEDLINE
Received Jun 30, 2026 · Event occurred Jun 3, 2026
Report 1423395-2026-00328 · MDR key 25667967
Device
Product problems
- Material Disintegration
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE OPTICLOSE RAPID GLUE WAS POPPED AS INTENDED. WHEN TECH STARTED TO APPLY TO PATIENT "GLASS SHARDS" WERE NOTICED COMING OUT OF THE TIP.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE OPTICLOSE RAPID GLUE WAS POPPED AS INTENDED. WHEN TECH STARTED TO APPLY TO PATIENT "GLASS SHARDS" WERE NOTICED COMING OUT OF THE TIP. GLUE WAS REMOVED FROM FIELD AND PATIENT WAS THOROUGHLY CLEANED. SURGEONS ARE HESITANT TO CONTINUE USAGE OF THIS GLUE ON FUTURE CASES. IT WAS DETERMINED AFTER THE TECH INITIALLY ACTIVATED THE GLUE, THEY WERE ABLE TO APPLY AS NORMAL. IT WAS THEN SET DOWN ON THE BACK TABLE ON A 4 X 4 AND ATTEMPTED TO BE USED AGAIN. WHEN TRYING TO REMOVE GLUE FROM THE 4 X 4, IS WHEN THE GLUE CAME APART AND "SHARDS" WERE NOTICED. WE BELIEVE THIS WAS A USER ERROR AND WE HAVE A SCHEDULED IN SERVICE FOR ENTIRE TEAM. NO CONCERNS FOR THE PATIENT. 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.