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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 Insufficient Information (3190)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the injector was not returned for evaluation for the report of a small metallic object embedded in the iris; 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. Metal objects can come from numerous instruments used during cataract surgery. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
 
Event Description
A surgeon reported that a patient who has a small metallic object embedded in her iris (very small, less than a millimeter) which appeared after uneventful cataract surgery performed. Additional information was provided by the surgeon, who reported "at this time its unclear if this was from surgical instrumentation or the actual composition of the object seen in the eye. " there are two medical device reports associated with this patient. This report is for the handpiece.
 
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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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7251143
MDR Text Key99836366
Report Number2523835-2018-00057
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 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
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 Received01/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/08/2018 Patient Sequence Number: 1
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