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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. PACKER/CHANG IOL CUTTER; OPTHALMIC SCISSOR
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MICROSURGICAL TECHNOLOGY, INC. PACKER/CHANG IOL CUTTER; OPTHALMIC 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 07/22/2014
Event Type  malfunction  
Event Description
The facility reported that while using a packer/chang iol scissor to cut a haptic on a 20 year old iol, the scissor stopped working.Upon removing the scissor from the eye for inspection, the blade fell off.The scissor was taken out of service and there was no impact to the patient.
 
Manufacturer Narrative
The scissor was returned dirty and corroded at the site of the break indicating it had not been maintained adequately per the instructions for use.
 
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Brand Name
PACKER/CHANG IOL CUTTER
Type of Device
OPTHALMIC SCISSOR
Manufacturer (Section D)
MICROSURGICAL TECHNOLOGY, INC.
redmond WA
Manufacturer Contact
8415 154th ave., n.e.
redmond, WA 98052
4255560544
MDR Report Key4055396
MDR Text Key4731886
Report Number3019924-2014-00029
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 08/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2014
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 Number038584
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/30/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/23/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2006
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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