MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Clouding/Hazing (1878)

Event Date 06/22/2018

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 multiple post operation reaction (haziness) with approximately 20 patients.Sample of the air and fluid results indicate a culture developed.The customer refused to share any further information on affected patients and product.

Manufacturer Narrative

The lot complaint history was reviewed.This is the first complaint for the finished goods lot and for this issue for this lot.The device history record shows the product was released per specifications.No sample was received.Therefore, no visual inspection or functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.If a sample is returned at a later date, the investigation will be reopened and the sample investigated.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 7695578
• MDR Text Key: 114228102
• Report Number: 1644019-2018-00171
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 8065751058
• Device Lot Number: 2111318H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention