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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 Problems Crack (1135); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2017
Event Type  malfunction  
Event Description
Additional information was received in a completed questionnaire. The haptics were placed over the lens and when they released, a crack was seen centrally on the iol. It was noted that the "kissing" haptics were not on top of each other but were next to each other. It was clarified that in the surgeon's opinion, it is unknown if the device caused or contributed to the event. This is one of two medical device reports for this event.
 
Manufacturer Narrative
Evaluation summary: one handpiece injector was returned for evaluation for the report of a cracked iol. A visual inspection of the iol handpiece injector was performed and was deemed nonconforming. The plunger has an upward position. A functional thread to barrel engagement check was performed and deemed conforming. A dimensional plunger position height check was performed and deemed nonconforming. The plunger position was high. The handpiece injector was manufactured in may 2013. The evaluation does confirm the injector plunger has a high plunger position which may have contributed to the cracked lens. The root cause for the nonconforming plunger height condition is usually from its use or handling, but when and how the plunger position became high cannot be determined from this evaluation. Based on the injector being manufactured over four years ago, the complaint issue does not point to a manufacturing issue. (b)(4).
 
Manufacturer Narrative
Additional information provided. The device was received by a company representative and is in transit to the manufacturing site for investigation. Investigation including root cause analysis will be completed. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria. A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
The product 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 doctor of ophthalmology reported that during a cataract removal with intraocular lens (iol) implant procedure, the injector cracked the lens next to the center and the lens haptics were stuck on top of the lens. It was noted that there had been no problems pushing the lens out. The procedure was completed following a 30 minute delay; the cracked lens was taken out and replaced with a new one. Clarification was received that the nurse's folding of the lens is the suspected cause of the event. 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, 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 Key7168998
MDR Text Key241266217
Report Number2523835-2018-00009
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K063155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIII
Device Catalogue Number8065977773
Device Lot Number929258M
Other Device ID Number00380659777738
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/05/2018 Patient Sequence Number: 1
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