EYE SERVICE MINOR PROCEDURE

Description of Event or Problem

THE CUSTOMER REPORTED THAT COTTON ON WOOD COTTON TIP APPLICATOR IS NOT CONSISTENTLY TIGHTLY SPUN. THE FIRST TIME THIS HAPPENED; SOME COTTON DID FALL OFF AND ENTER THE WOUND. IT WAS SUCCESSFULLY REMOVED WITH FORCEPS. THE COTTON TIP APPLICATOR IS CONTAINED IN A CONVENIENCE KIT MANUFACTURED BY AVID MEDICAL. THE SITE HAS BEEN CHECKING THESE PRIOR TO USE.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT IS NOT AVAILABLE FOR EVALUATION. AVID MEDICAL IS A CONVENIENCE KIT MANUFACTURER. THE COMPLAINT COMPONENT IS PURITAN MEDICAL PRODUCTS CO (REGISTRATION NUMBER: 1216735) PART NUMBER 5308915, LOT NUMBER 26967. A SUPPLIER CORRECTIVE ACTION (SCAR) WAS ISSUED TO THE COMPONENT MANUFACTURER ON MAY 21, 2026. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.