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 Date 05/10/2017

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.(b)(4).

Event Description

A doctor reported that an irrigation / aspiration tip presented with a burr during a procedure.The patient experienced a posterior capsular tear.Additional information has been requested but none has been received.

Manufacturer Narrative

(b)(4).

Event Description

New information received from the customer stating the event occurred while polishing the posterior capsule on polish mode.A three (3) piece intraocular lens was inserted in the sulcus.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

One polymer angled i/a tip was returned for evaluation for the report of burr inside the tip that resulted in a capsule tear.Further information indicates the customer reports this burr is at 12 o¿clock in the aspiration hole.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 was one additional complaints associated with the lot for the reported issue from the same entity.A visual inspection was performed and deemed conforming.The aspiration hole has a very small ridge of plastic along the sides of the aspiration hole, but no flash on the top radius at the 12 o-clock position.This is an acceptable condition.A small mismatch of the parting line, unrelated to the reported complaint issue, was observed and was confirmed dimensionally as acceptable.The complaint evaluation does not confirm the polymer ia tip has nonconforming burr in the aspiration hole that would have caused the capsule tear.The tip was manufactured to specification.The reason for the capsule tear cannot be determined from this evaluation.The manufacturer internal reference number is: (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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6727688
• MDR Text Key: 80517935
• Report Number: 2523835-2017-00594
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2017

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 Date: 04/30/2019
• Device Catalogue Number: 8065751511
• Device Lot Number: 198445M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 07/25/2017; 09/25/2017; 10/09/2017
• Supplement Dates FDA Received: 07/27/2017; 09/26/2017; 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR