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

Catalog Number 11429

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxicity (2333)

Event Date 08/16/2017

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that a case of toxic anterior segment syndrome was confirmed.This is one of two reports being filed for this facility.Additional information and product samples have been requested.

Manufacturer Narrative

All batches were released according to the required specifications.The customer did not retain a sample for this complaint; therefore, visual inspection could not be conducted.The root cause of the customer's complaint is not known; a sample was not returned for investigation.Without a sample, it is not possible to isolate the root cause.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.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received.The symptoms were noted one week postoperatively.Toxic anterior chamber syndrome (tass) was considered the current diagnosis in this case.Associated complications of the event were corneal edema and fibrin on the intraocular lens.The patient has been treated with ocular medications and the symptoms are expected to resolve with treatment.

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6878396
• MDR Text Key: 86705631
• Report Number: 1644019-2017-00724
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Catalogue Number: 11429
• Device Lot Number: 2022388H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2017
• 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
• Treatment: DUOVISC, VISCOELASTIC SYSTEM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR