MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. MALYUGIN RING SYSTEM; CLIP, IRIS RETRACTOR

Model Number	MAL-0001-1
Medical Device Problem Codes	Retraction Problem (1536); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
During cataract surgery the malyugin ring's subincisional ring disengaged and was caught behind the iol.The surgeon was forced to cut the ring out of the eye leaving a small portion of it in the capsulor bag with the iol.
Additional Manufacturer Narrative
The portion of the device that was able to be removed from the patient's eye was not returned for evaluation.The surgery was completed and an iol was implanted.The patient was reported to be doing well and showing no signs of inflamation.

• Brand Name: MALYUGIN RING SYSTEM
• Common Device Name: CLIP, IRIS RETRACTOR
• 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: 20021514
• Report Number: 3019924-2024-00009
• Device Sequence Number: 20695198
• Product Code: HOC
• UDI-Device Identifier: 00844685000029
• UDI-Public: 00844685000029
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAL-0001-1
• Device Catalogue Number: MAL-0001-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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