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

Catalog Number 8065750541

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

Patient Problem No Code Available (3191)

Event Date 09/04/2018

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 surgeon reported a patient developed toxic anterior segment syndrome postoperatively.The surgeon indicated the patient required an unspecified intervention and the symptoms are continuing.The patient condition improved with slight haze on the lens surface.Additional information was requested; however, none has been received to date.This is one of three reports for this surgeon.

Manufacturer Narrative

The lot complaint history was reviewed; this is the third complaint for the finish goods lot and third for this issue for this lot.The device history record (dhr) shows the product was released per specifications.A review of the dhr for the reported suspect product also confirms that this product has been sterilized and all sterilization cycle parameters were verified for acceptability prior to release.A sample was expected for this investigation but has not yet been received.Without a sample, visual inspection or functional evaluation was unable to be performed.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 an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: LAUREATE 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: 7915579
• MDR Text Key: 121924567
• Report Number: 1644019-2018-00231
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 8065750541
• Device Lot Number: 2139730H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LAUREATE WORLD PHACO SYSTEM; LAUREATE WORLD PHACO SYSTEM
• Patient Outcome(s): Other