Description of Event or Problem · 0
THE MANUFACTURER BECAME AWARE OF THIS EVENT ON 12/9/2025 FOLLOWING FDA CORRESPONDENCE REFERENCING A VOLUNTARY REPORT IN WHICH A PATIENT ALLEGED THAT EXPIRED PDO MAX SMOOTH THREADS WERE USED DURING A COSMETIC PROCEDURE AND THAT THE PATIENT SUBSEQUENTLY EXPERIENCED BLURRY VISION IN THE RIGHT EYE CORRESPONDING TO THE TREATED AREA. THE PATIENT'S REPORT STATES THAT THE PRODUCT PACKAGING DISPLAYED AN EXPIRATION DATE OF JUNE 2025 AND THAT, AT THE TIME OF THE PROCEDURE IN 2025, THE PRODUCT WAS PAST ITS LABELED EXPIRATION DATE. UPON RECEIPT OF FDA'S LETTER DESCRIBING AN ASSOCIATED ADVERSE EVENT, THE MANUFACTURER INITIATED A COMPLAINT INVESTIGATION AND MDR ASSESSMENT. DISTRIBUTION AND DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LOT(S) IDENTIFIED. THESE RECORDS CONFIRM THAT PRODUCT SHIPPED TO THE CUSTOMER IN SEPTEMBER 2023 WAS WITHIN ITS LABELED EXPIRATION DATE AND MET RELEASE SPECIFICATIONS AT THE TIME OF DISTRIBUTION. THE DEVICE LABELING AND INSTRUCTIONS FOR USE STATE THAT THE PRODUCT MUST NOT BE USED AFTER THE LABELED EXPIRATION DATE. USE OF PRODUCT BEYOND ITS EXPIRATION DATE IS INCONSISTENT WITH THE PRODUCT LABELING AND IS UNDER THE CONTROL OF THE USER FACILITY/PRACTITIONER. BASED ON THE AVAILABLE INFORMATION, NO DEVICE MALFUNCTION OR LABELING DEFICIENCY HAS BEEN IDENTIFIED.