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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON ALCON SN6CWS 23.0 DIOPTER

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ALCON ALCON SN6CWS 23.0 DIOPTER Back to Search Results
Model Number SN6CWS
Event Date 06/19/2012
Event Type  Injury  
Event Description

Alcon model sn6cws preloaded 23. 0 diopter sn (b)(4) was injected in the eye. It did not inject smoothly and then the plunger released rapidly and forced the lens forward creating a tear in the capsular bag. The device design is poor and at risk for serious ocular damage.

 
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Brand NameALCON
Type of DeviceSN6CWS 23.0 DIOPTER
Manufacturer (Section F)
ALCON
fort worth TX
Manufacturer (Section D)
ALCON
fort worth TX
Device Event Key2662907
MDR Report Key2631617
Event Key2528313
Report NumberMW5025952
Device Sequence Number1
Product CodeHQL
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 06/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Device EXPIRATION Date02/28/2016
Device MODEL NumberSN6CWS
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2012
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 06/19/2012 Patient Sequence Number: 1
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