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

Model Number MAL-0002-1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

The user facility reported to the distributor that the malyugin ring tore a capsule when being inserted into the pupillary margin.The surgeon was able to salvage the capsular bag and implant and iol without further impact to the pt.

Manufacturer Narrative

The eval on the returned device was inconclusive.The cause of the capsular tear is unk.

• Brand Name: MALYUGIN RING SYSTEM
• Type of Device: IRIS CLIP RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; redmond WA
• Manufacturer Contact: 8415 154th ave., n.e.; redmond, WA 98052 ; 4255560544
• MDR Report Key: 4346067
• MDR Text Key: 5199661
• Report Number: 3019924-2014-00056
• Device Sequence Number: 1
• Product Code: HOC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/05/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MAL-0002-1
• Device Catalogue Number: MAL-0002-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other