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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 Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis for the report of a torn haptic; therefore, the condition of the product could not be verified. 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, there was an issue with the delivery system with a description that a haptic was torn. The iol did touch the eye. Additional information has been requested.
 
Event Description
Additional information was provided indicating that the iol delivery system was not involved. The torn haptic was noticed upon opening the package. There was no patient contact and the procedure was completed with a new lens.
 
Manufacturer Narrative
Additional information was provided. Based on information received following submission of the initial report, this event does not meet criteria for reporting as a (serious injury/device malfunction/incident) for this product as this product was not involved in the event. The manufacturer internal reference number is: (b)(4).
 
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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
MDR Report Key7994938
MDR Text Key124811146
Report Number2523835-2018-00436
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
PMA/PMN Number
K063155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/23/2018 Patient Sequence Number: 1
Treatment
MONARCH D CARTRIDGE; SN60WF 22.5 DIOPTER
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