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

Model Number	STREAMLINE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the lot involved was reviewed and no issues observed.Product was manufactured, tested, and released per validated procedures.Device was discarded after surgery and is not available for review.Communication/interview with surgeon confirmed user pumped visco at the same location.
Event or Problem Description
Cataract extraction with phacoemulsification combined with the streamline surgical system device completed.Per surgeon, multiple button clicks in the same location led to a small descemet membrane detachment.Surgeon was unsure whether the first click got into the proper space so clicked button again.Detachment is moving 1 week post-op.

• Brand Name: STREAMLINE SURGICAL SYSTEM
• Common Device Name: PUMP, INFUSION, OPHTHALMIC
• Manufacturer (Section D): NEW WORLD MEDICAL; 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: 13664515
• Report Number: 1000125279-2022-00004
• Device Sequence Number: 5474769
• Product Code: MRH
• UDI-Device Identifier: 00892064002010
• UDI-Public: (01)00892064002010(11)211112(17)221112(10)K1621
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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 Expiration Date: 11/12/2022
• Device Model Number: STREAMLINE
• Device Catalogue Number: STREAMLINE
• Device Lot Number: K1621
• 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: 02/03/2022
• Initial Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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: Other
• Patient Sex: Unknown