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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. PACKER/CHANG IOL CUTTER
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MICROSURGICAL TECHNOLOGY, INC. PACKER/CHANG IOL CUTTER Back to Search Results
Model Number DFH-0012
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The surgeon reported that the packer/chang iol scissor broke when he attempted to cut a three piece acrylic iol.There was no impact to the patient and the broken piece was removed from the eye.
 
Manufacturer Narrative
The scissor was returned dirty, corroded and with damage that is indicative of the scissor being used to cut too hard an object.The surgeon reported that he was attempting to use the scissor to cut a three piece acrylic iol.This scissor is indicated to cut soft foldable iols.
 
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Brand Name
PACKER/CHANG IOL CUTTER
Manufacturer (Section D)
MICROSURGICAL TECHNOLOGY, INC.
redmond WA
Manufacturer Contact
8415 154th ave., n.e.
redmond, WA 98052
4255560544
MDR Report Key3941040
MDR Text Key4578819
Report Number3019924-2014-00013
Device Sequence Number1
Product Code HNF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Physician
Remedial Action Replace
Type of Report Initial
Report Date 04/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDFH-0012
Device Catalogue NumberDFH-0012
Device Lot Number044854
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/11/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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