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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH LTD/HUNTINGTONACRYSERT DELIVERY SYSTEMLENS GUIDE

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ALCON RESEARCH LTD/HUNTINGTON ACRYSERT DELIVERY SYSTEM LENS GUIDE   Back to Search Results
Catalog Number SN6CWS
Device Problems Use of Device Issue; Inaccurate delivery
Event Date 03/02/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

Product evaluation: the lens and the device were returned for evaluation. Solution is dried on the lens. Lens damage was observed to the optic. The device was returned and no damage was observed. The plunger is fully advanced. The observed solution does not appear to be an approved viscoelastic. Results from the product history record review indicated the product met release criteria. Root cause: the root cause could not be determined by the product evaluation. However, due to information provided, the event may have occurred due to a failure to follow the dfu. The customer used an unapproved viscoelastic in the device. Viscosity of an unapproved ovd may contribute to underfill/overfill, misfolding of the trailing haptic, lack of lubricity or other unpredictable outcomes. Action taken: no further action is warranted at this time. Complaint trends will continue to be monitored and further action will be initiated when deemed necessary by the appropriate responsible management personnel. There have been no other complaints reported in the lot number. Additional information has been requested. (b)(4).

 
Event Description

A supply officer reported that during intraocular lens (iol) implant surgery, during the final phase the iol shot out and through the posterior capsule (pc) with vitreous loss. The surgeon reported the patient was for second eye surgery with extremely dense cataract. The senior surgeon did his first eye which was difficult with an excellent result. This report is for the second eye. The senior surgeon supervised a trainee to do the second eye to expand his experience. The surgery went well and was uncomplicated. The bag was filled fully with viscoelastic and the nurse who has been trained in the lens injector system filled the injector appropriately. The surgeon slowly injected the lens. Ninety percent of the lens had exited the tip without a problem. The injector then stalled a little and with the lens progress stalled, the surgeon applied a small increase in pressure commensurate with any injector and the lens shot out. The lens went through the pc with extensive vitreous loss and half the lens in the posterior chamber. The senior surgeon took over and explanted the lens carefully. An anterior vitrectomy was performed with a sulcus iol placed. Sutures were required. The trainee has used the injector on around 20 patients appropriately. An unapproved viscoelastic was used during the surgical procedure. Additional information has been requested.

 
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Brand NameACRYSERT DELIVERY SYSTEM
Type of DeviceLENS GUIDE
Manufacturer (Section F)
ALCON RESEARCH LTD/HUNTINGTON
6065 kyle lane
huntington WV 25702
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
charles dolbee
6201 south freeway, r7-18
fort worth , TX 76134
(817) 551 -8317
Device Event Key2086739
MDR Report Key2051216
Event Key1948192
Report Number1119421-2011-00374
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional,Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 03/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/30/2015
Device Catalogue NumberSN6CWS
Device LOT Number11033276
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/16/2011
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received03/07/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/06/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
HPMC WAS USED TO FILL THE DELIVERY SYSTEM
SYRINGE
PROVISC USED IN THE EYE.
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