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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number III
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: no injector was returned for evaluation for not working correctly; therefore, the condition of the product could not be verified. There was no injector lot number 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 nurse reported that during an intraocular lens (iol) implant procedure, the injector did not engage the lens correctly. According to the scrub it was probably a loading error. There was no eye injury.
 
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Brand NameMONARCH III IOL DELIVERY SYSTEM, INJECTOR
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
714 columbia avenue
sinking spring PA 19608
Manufacturer (Section G)
ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
714 columbia avenue
sinking spring PA 19608
Manufacturer Contact
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7790862
MDR Text Key117603833
Report Number2523835-2018-00381
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIII
Device Catalogue Number8065977773
Device Lot NumberASKU
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 Received07/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/16/2018 Patient Sequence Number: 1
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