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

Catalog Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

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 patient returned for an office visit and a small fiber was seen in the eye.The patient was taken to the operating room and foreign body removed.Two weeks later another fiber was seen in the anterior chamber and the surgeon has decided to leave in the eye at this time.To date the patient is stable and has no reported harm.No fiber samples available.

Manufacturer Narrative

The lot complaint history was reviewed; this is the fourth complaint for the finish goods lot and fourth for this issue for this lot.The device history record shows the product was released per specifications.It has been noted all four complaints have originated from the same customer within a two day period.The root cause of the customer's complaint could not be established as a sample has not been received.Without a 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.Action will not be taken for this occurrence as no sample was returned and 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.Manufacturing management and quality engineering materials will be made aware of this complaint through the monthly complaint review meeting.It is recommended that the customer place the surgical instruments on a mayo tray and if applicable avoid placing them directly on a mayo stand cover or the back table cover.Additionally, the instruments should be wiped before passing back to the surgeon.This will assist in preventing lint contamination on instruments and help to reduce the risk of lint getting into the patient eye.(b)(4).

• 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7996974
• MDR Text Key: 124789254
• Report Number: 1644019-2018-00250
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Catalogue Number: ASKU
• Device Lot Number: 2164522H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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: 67 YR
• Patient Weight: 73