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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. PACKER/CHANG IOL CUTTER; OPHTHALMIC SCISSOR
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MICROSURGICAL TECHNOLOGY, INC. PACKER/CHANG IOL CUTTER; OPHTHALMIC SCISSOR Back to Search Results
Model Number DFH-0012
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2014
Event Type  malfunction  
Event Description
The facility reported that while using a packer/chang iol scissor to cut an older iol the scissor blade broke.The doctor was able to make a first cut but when he attempted to make a second cut the scissor broke.The broken piece was removed from the eye and there was no impact to the patient.
 
Manufacturer Narrative
The scissor was broken in a fashion that indicates it was used to cut too hard of an object.The directions for use state the device is to be used to cut soft fold-able iols.
 
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Brand Name
PACKER/CHANG IOL CUTTER
Type of Device
OPHTHALMIC SCISSOR
Manufacturer (Section D)
MICROSURGICAL TECHNOLOGY, INC.
redmond WA
Manufacturer Contact
8415 154th ave., n.e.
redmond, WA 98052
4255560544
MDR Report Key4189323
MDR Text Key5158138
Report Number3019924-2014-00041
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
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 09/30/2014
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
Device Operator Health Professional
Device Model NumberDFH-0012
Device Catalogue NumberDFH-0012
Device Lot Number044854
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/23/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/09/2014
Initial Date FDA Received09/30/2014
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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