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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 10/09/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the investigation is in progress. A sample is expected, but has not been received at the investigation facility at this time. Based on the preliminary investigation findings, there has been no change in criticality for this complaint. No lot number was identified with this complaint; therefore, a lot history review could not be conducted. A root cause has not been identified. The root cause will be reassessed upon completing the investigation. Additional information was requested. The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported during the implant of an intraocular lens (iol), the handpiece was hard to load the lens. This caused the lens haptic to be scratched and torn. Additional information was requested.
 
Manufacturer Narrative
Additional information was provided. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Additional information provided. 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 Key8005881
MDR Text Key125283183
Report Number2523835-2018-00439
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
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIII
Device Catalogue Number8065977773
Device Lot Number734519M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2019
Is This a Reprocessed and Reused Single-Use Device? Yes

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