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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 02/17/2015
Event Type  malfunction  
Event Description
The facility reported that the packer/chang iol cutter blade broke off when the surgeon attempted to cut on iol.The broken blade fell to the back of the eye and the pt was referred to a retinal surgeon.There was no impact to the pt and the broken blade was removed from the eye.
 
Manufacturer Narrative
At the time of this report the scissor had not been returned for eval.
 
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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 Key4645076
MDR Text Key5681606
Report Number3019924-2015-00016
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 Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 03/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDFH-0012
Device Catalogue NumberDFH-0012
Device Lot Number048234
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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