MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. STREAMLINE SURGICAL SYSTEM; INFUSION PUMP

Model Number	STREAMLINE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.(b)(6) decemet's detachment.The surgeon/customer is not expecting follow-up communication.
Additional Manufacturer Narrative
The ifu for the reported product model was reviewed and confirmed to include descemet's membrane tear or detachment as a known complication.The device history record (dhr) was reviewed and found no issues.The product was manufactured, tested, and released in accordance with validated procedures.As the device is not available for return, no device malfunction could be confirmed.

• Brand Name: STREAMLINE SURGICAL SYSTEM
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9094664304
• MDR Report Key: 24598467
• Report Number: 1000125279-2026-00006
• Device Sequence Number: 15545091
• Product Code: MRH
• UDI-Device Identifier: 00892064002102
• UDI-Public: (01)00892064002102(11)251114(17)281114(10)L1725
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K211680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: STREAMLINE
• Device Catalogue Number: STREAMLINE
• Device Lot Number: L1725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown