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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 10/23/2014
Event Type  malfunction  
Event Description
The surgeon reported that while using a packer/chang iol scissor to cut an iol the scissor blade broke.The broken piece was removed from the eye and there was no impact to the patient.
 
Manufacturer Narrative
The packer/chang iol cutters have a life expectancy of 3 years.The device evaluated was over 5 years old and had corrosion and pitting at the site of the break but was otherwise free of corrosion indication the device had been maintained adequately however failed due to wear and tear associated with reaching its life expectancy.
 
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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 ne
redmond, WA 98052
4255560544
MDR Report Key4289137
MDR Text Key16542423
Report Number3019924-2014-00052
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 Health Professional,User Facility
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 11/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2014
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 Number024206
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/04/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2008
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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