• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

ALCON RESEARCH, LTD. / HUNTINGTON ACRYSERT DELIVERY SYSTEM LENS GUIDE   Back to Search Results
Catalog Number SN6CWS
Device Problem Inaccurate delivery
Event Date 07/26/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

A surgeon reported for a colleague that during intraocular lens (iol) implant surgery, there was a sudden ejection of the lens. In a follow up from the implanting surgeon, it was reported that the lens suddenly ejected from the device causing a posterior capsular rupture with the lens going into the vitreous. An anterior and posterior vitrectomy were performed. The lens was left in place and exchanged in a secondary surgical procedure at a different facility. The surgeon reported the event resolved following the lens exchange.

 
Manufacturer Narrative

Eval summary: the product was not returned for analysis. Results from the product history record review indicated the product met release criteria. The root cause could not be identified by the investigation. Add'l info was requested and rec'd. (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 MANUFACTURING, LTD.
6065 kyle lane
huntington WV 25702
Manufacturer Contact
paul nitschmann
6201 south freeway, r3-16
fort worth , TX 76134
(817) 615 -2440
Device Event Key2494796
MDR Report Key2468816
Event Key2365629
Report Number1119421-2012-00223
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/31/2015
Device Catalogue NumberSN6CWS
Device LOT Number11065497
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/24/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2010
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: 02/22/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
PROVISC
SN6CWS
-
-