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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number SN6CWS
Device Problems IOL (Intraocular Lens) Implant; Device Operates Differently Than Expected; Mechanical Jam; Haptic
Event Date 05/14/2015
Event Type  Injury  
Event Description

An ophthalmic surgeon reported following an intraocular lens (iol) implant surgery she found the iol haptic stuck onto the front side of the iol optic during an examination. The iol haptic was removed from the iol optic during a second procedure. Additional information was received from the surgeon reporting the patient had conjunctivitis and conjunctival edema.

 
Event Description

Additional information was received by the surgeon reporting the patient has recovered from the conjunctivitis and conjunctival edema. The patient has been started on a steroid.

 
Manufacturer Narrative

Evaluation summary: the product was not returned for analysis; the lens remains implanted. The results from the product history record review indicated the product met release criteria. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. Additional information was requested and received. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Additional information was provided. Evaluation summary. A dvd was received and reviewed. The lens was already in the eye. A haptic was observed adhered to the anterior optic surface near the outer edge. The haptic was slowly worked loose from the optic surface. Lens was centered and remains implanted. The root cause may be related to a failure to follow the dfu. The haptic was observed to be adhered to the optic. The haptic was successfully released during the surgery. The initial surgery was not provided so the device preparation remains unknown. A failure to follow the dfu was indicated in the use of an unqualified viscoelastic. The use of an unqualified viscoelastic may contribute to underfill, overfill, misfolding of the trailing haptic, lack of lubricity or other unpredictable outcomes, which may result in lens damage or delivery issues. This event may occur due to operating room temperatures too high (greater than 23°c / 73° f), which may make the lens more adherent. The manufacturer internal reference number is: (b)(4).

 
Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

 
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Brand NameACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth , TX 76134
8175686660
MDR Report Key4847369
Report Number1119421-2015-05593
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Foreign,Health Professional,FOREIGN,HEALTH PROFESSI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 09/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2016
Device MODEL NumberSN6CWS
Device Catalogue NumberSN6CWSQ225
Device LOT Number12115248
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/13/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/16/2015 Patient Sequence Number: 1
Treatment
STEROID
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