STREAMLINE SURGICAL SYSTEM
Received Apr 23, 2026 · Event occurred Apr 1, 2026
Report 1000125279-2026-00015 · MDR key 24966024
Device
Generic name
Infusion Pump
Manufacturer
New World Medical, Inc.Model number
STREAMLINECatalog number
STREAMLINE
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Eye Injury
Narrative
Additional Manufacturer Narrative
THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY EVALUATED. RESIDUAL DRIED OVD MATERIAL AND MINOR DISTAL TIP DEFORMATION WERE OBSERVED. THE DEVICE ACTUATED AND FUNCTIONED AS INTENDED, WITH NO FUNCTIONAL ABNORMALITIES IDENTIFIED. BASED ON THE EVALUATION, A DEVICE MALFUNCTION CONTRIBUTING TO THE REPORTED DESCEMET'S MEMBRANE DETACHMENT COULD NOT BE CONFIRMED.
Additional Manufacturer Narrative
THE IFU FOR THE REPORTED PRODUCT MODEL WAS REVIEWED AND CONFIRMED TO INCLUDE DESCEMET'S DETACHMENT AS A KNOWN COMPLICATION. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED, AS NO SPECIFIC SERIAL OR LOT INFORMATION WAS AVAILABLE. THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH VALIDATED PROCEDURES. DEVICE RETURN IS PENDING CONFIRMATION OF AVAILABILITY. IF THE DEVICE IS RETURNED TO NEW WORLD MEDICAL, AN ADDENDUM WILL BE FILED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem
DESCEMET MEMBRANE DETACHMENT WHEN USING STREAMLINE.