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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 Problem Device Damaged by Another Device (2915)
Patient Problem Visual Impairment (2138)
Event Date 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
A sample device was not returned for analysis. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported that following an intraocular lens (iol) implant procedure, the lens had a scratch and patient experienced poor vision. The iol was exchanged in a secondary procedure 35 days following the initial procedure. Additional information has been requested and provided that there was no patient harm and no hospitalization.
 
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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
8007579780
MDR Report Key13384406
MDR Text Key284677813
Report Number2523835-2022-00029
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,Followup
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
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
Date Manufacturer Received04/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/28/2022 Patient Sequence Number: 1
Treatment
ACRYSOF IQ PANOPTIX; ACRYSOF IQ PANOPTIX; MONARCH III IOL, CARTRIDGE D; PROVISC
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