MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. MST MALYUGIN RING; IRIS CLIP

Model Number	MAL-0001-1
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.It was reported that when the surgeon was removing the ring from the eye it broke and there was trauma to the iris.
Event or Problem Description
The distributor reported that the surgeon had difficulty removing the ring from the and there was subsequent iris damage.

• Brand Name: MST MALYUGIN RING
• Common Device Name: IRIS CLIP
• 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: 13198755
• Report Number: 3019924-2021-00005
• Device Sequence Number: 19254151
• Product Code: HOC
• UDI-Device Identifier: 00844685000029
• UDI-Public: 00844685000029
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 03/17/2023
• Device Model Number: MAL-0001-1
• Device Catalogue Number: MAL-0001
• Device Lot Number: 121131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown