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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number III
Device Problems Scratched Material (3020); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. The product investigation could not identify a root cause. Additional information has been requested. (b)(4).
 
Event Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the inserter rolled over the optic and scratched the lens was when inserting. The lens was removed and replace during the initial procedure. There was no patient harm. Additional information has been requested.
 
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Brand NameMONARCH III IOL DELIVERY SYSTEM, INJECTOR
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
714 columbia avenue
sinking spring PA 19608
Manufacturer (Section G)
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
714 columbia avenue
sinking spring PA 19608
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10610291
MDR Text Key209549806
Report Number2523835-2020-00214
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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