• 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. - ALCON PRECISION DEVICE MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED LENS, GUIDE, INTRAOCULAR

  • 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. - ALCON PRECISION DEVICE MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number ASKU
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the injector was not returned for evaluation for the report of injector plunger moving past the lens; therefore, the condition of the product could not be verified. No lot number was identified with this complaint; therefore, a lot history review could not be conducted. The root cause for the customer complaint issue cannot be determined. (b)(4).
 
Event Description
A purchasing agent reported that during an intraocular lens (iol) implant procedure, the plunger moved past the lens. There was patient contact.
 
Event Description
Additional information was provided indicating that the event occurred before the procedure, there was no patient contact and the procedure was completed.
 
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
714 columbia avenue
sinking spring PA 19608
MDR Report Key7577970
MDR Text Key110734063
Report Number2523835-2018-00246
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 08/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberASKU
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/07/2018 Patient Sequence Number: 1
-
-