MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. MST ALLEGRO SP; OPHTHALMIC CANNULA

Model Number	ASP-0001-P-1
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The distributor reported that the surgeon experienced a posterior capsule tear during ia.A pars plana vitrectomy was performed and a sulcus iol was implanted.The patients are reported to be doing well.
Event or Problem Description
The distributor reported that the surgeon experienced a posterior capsular tear during irrigation and aspiration of cortex under main incision.

• Brand Name: MST ALLEGRO SP
• Common Device Name: OPHTHALMIC CANNULA
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: cecil chrisinger ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 13199001
• Report Number: 3019924-2021-00007
• Device Sequence Number: 13836275
• Product Code: HMX
• UDI-Device Identifier: 00844685006762
• UDI-Public: 00844685006762
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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: 03/01/2024
• Device Model Number: ASP-0001-P-1
• Device Catalogue Number: ASP-0001-P
• Device Lot Number: 136466
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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