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

Catalog Number 8065751511

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Capsular Bag Tear (2639)

Event Type  Injury  

Manufacturer Narrative

A sample has been received and in-house testing is in progress.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

An ophthalmic surgeon reported that during the irrigation/aspiration (i/a) portion of a surgical procedure the patient experienced a capsule rupture.An anterior vitrectomy was performed to remove the vitreous present in the anterior chamber.It was noted that the surgeon suspects that there is a protrusion on the tip of the i/a cannula.The aspiration port was facing upward.Additional information has been requested.

Manufacturer Narrative

Two opened ia tips and three opened capsules were received in a plastic bag for the report of burr on tip.The samples were visually inspected.One sample was found conforming and one sample was non-conforming with a slice in the tip.A review of the device history record 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 are no additional complaints associated with the lot for the reported issue.The returned non-conforming sample was received opened, loose in a bag; therefore, how and when the tip became damaged cannot be determined from this evaluation.The most likely contributing factor is damage from contact with another instrument during use.(b)(4).

• Brand Name: DISPOSABLE POLYMER IRRIGATION AND 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6459675
• MDR Text Key: 71683697
• Report Number: 2523835-2017-00229
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 8065751511
• Device Lot Number: 179096M
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention