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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 Type  malfunction  
Event Description
The surgeon reported that the packer/chang iol cutter broke when he attempted to cut an iol.There was no impact to the pt and the broken piece was removed from the eye.
 
Manufacturer Narrative
The device was returned for evaluation.Dirty, rusty and corroded in a way that suggest the device was not properly cleaned and maintained according to the directions for use.There were two broken scissors from the same lot reported, however they occurred during different procedures and on different pts.This is the second of two reports.
 
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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 Key3694901
MDR Text Key16087332
Report Number3019924-2014-00006
Device Sequence Number1
Product Code HNF
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 01/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2014
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 Number045060
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/15/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2012
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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