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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. MST MALYUGIN RING; IRIS CLIP RETRACTOR
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MICROSURGICAL TECHNOLOGY INC. MST MALYUGIN RING; IRIS CLIP RETRACTOR Back to Search Results
Model Number MAL-1002-1
Device Problem Material Deformation (2976)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
The surgeon reported that the haptic of the iol tangled in the ring and pulled it into the bag.The surgery was completed and the ring was left in the eye.
 
Manufacturer Narrative
The surgeon reported that he was able to remove the ring during a follow-up procedure.The patient was reported to be recovering well.
 
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Brand Name
MST MALYUGIN RING
Type of Device
IRIS CLIP 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 Key13161240
MDR Text Key285807212
Report Number3019924-2021-00004
Device Sequence Number1
Product Code HOC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMAL-1002-1
Device Catalogue NumberMAL-1002-1
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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