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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

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ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY Back to Search Results
Catalog Number 8065740970
Device Problem Insufficient Information (3190)
Patient Problem Capsular Bag Tear (2639)
Event Date 07/16/2015
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
A surgeon reported that during a cataract extraction with intraocular lens implant procedure there were four patients that experienced posterior capsule tears (pc tear).The surgeon suspects the irrigation/aspiration tip to have caused the pc tears.This report is for two of the four patients for this reported event.Additional information has been requested, but none has been received to date.
 
Manufacturer Narrative
The returned samples were inspected per facility procedure (b)(4) and were determined to be visually conforming.The final customer lot was identified as sterile lot 112062m, manufactured in jun-2015.A device history record review for the lot was conducted.No anomaly was found during the device history record review.The product was released based on the product¿s acceptance criteria.No additional investigation is required based on device history review.A complaint history review indicates this is the third complaint received against the reported lot.The three complaints were received concurrently from the same account.The reason for the posterior capsule tear cannot be confirmed from the evaluation of the returned sample.Possible contributing factors are using the tip more than 10 times and the improper placement of the tip into the holder stand.Correspondence included with the complaint stated the facility practice includes usage in excess of the 10 times described in the directions for use.During cleaning, the direction for use instructions must be adhered to or the tip may become damaged.Silicone i/a tips must also be inspected for any damage present prior to each use.This investigation was opened for new tips, however, the returned samples were conforming to visual inspections and did not point to a cause for the rupture of the posterior capsule.(b)(4).
 
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Brand Name
SILICONE IRRIGATION AND ASPIRATION TIPS
Type of Device
DEVICE, IRRIGATION, OCULAR SURGERY
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
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686660
MDR Report Key5001803
MDR Text Key22943519
Report Number2523835-2015-00797
Device Sequence Number1
Product Code KYG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Followup
Report Date 11/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Catalogue Number8065740970
Device Lot Number112062M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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