• 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./ HUNTINGTON MONARCH UNK IOL DELIVERY SYSTEM CARTRIDGE C LENS GUIDE

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

ALCON RESEARCH, LTD./ HUNTINGTON MONARCH UNK IOL DELIVERY SYSTEM CARTRIDGE C LENS GUIDE Back to Search Results
Device Problems Use of Device Problem; Inaccurate Delivery ; Injection System
Event Date 08/26/2014
Event Type  Injury  
Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, the haptic broke causing a posterior capsule (pc) rupture. In a follow up, the surgeon reported there was a forceful entry of the iol, causing the pc rupture. The pc rupture was large enough to prevent another iol from being implanted, leaving the pt aphakic. The surgeon also reported the broken haptic did not enter the pt's eye. An anterior vitrectomy was also performed during the initial procedure. The surgeon reported he does not think the correct cartridge size was used during the procedure. The surgeon reported the event resolved with treatment, and will try to fit the pt in a contact lens. The surgeon indicated an unapproved lens/ cartridge combination was used during the implant procedure. Additional info has been requested. There are two medical device reports associated with this event. This report is for the cartridge. The medical device report for the intraocular lens was previously reported under mfr report # 1119421-2014-00740.

 
Manufacturer Narrative

Eval summary: the complaint sample was not returned by the reporting facility. Complaint history and product history records could not be reviewed for the cartridge because the facility did not provide a lot number or any identification traceable to the mfg documentation. Product history records were reviewed for the iol and all documents indicate the product met release criteria. The account used an unapproved lens/cartridge combination. This lens model is only qualified for use in a different model cartridge. The product was not returned and not enough info was provided from the account for further investigation. Additional info indicated the account used an unapproved lens/cartridge combination. Additional info has been requested. (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMONARCH UNK IOL DELIVERY SYSTEM CARTRIDGE C
Type of DeviceLENS GUIDE
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
janet moran
6201 south freeway, r3-48
fort worth , TX 76134
8176152742
MDR Report Key4135939
Report Number1119421-2014-00752
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/27/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/01/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/29/2014 Patient Sequence Number: 1
Treatment
SN60AT IOL
UNK VISCOELASTIC MATERIAL
-
-