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

Catalog Number 8065740970

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/12/2015

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 one of the four patients for this reported event.Additional information has been requested, but none has been received to date.

Manufacturer Narrative

A sample was not returned for evaluation; therefore, the condition of the product could not be verified.The final customer lot was identified as sterile lot 112062m.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 associated with the reported lot.Because no sample was returned and the device history review (dhr) of the lot number provided indicated product was released according to the product¿s acceptance criteria, the root cause for the defect experienced by the customer cannot be determined.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 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 used.(b)(4).

• 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 Key: 5001074
• MDR Text Key: 22883405
• Report Number: 2523835-2015-00798
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 8065740970
• Device Lot Number: 112062M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AMO SOVEREIGN SYSTEM
• Patient Outcome(s): Other