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

Catalog Number 14132

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2017

Event Type  malfunction  

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 doctor reported that needle shot off the syringe during surgery.The doctor felt that syringe and needle were loose when using the product.The product was replaced and procedure completed with no patient harm.The sample is not available for return.

Manufacturer Narrative

(b)(4).

Event Description

New information from customer indicates that the intraocular lens positioning failed due to posterior capsule damage.The patient is complaining that he is dissatisfied with the different appearance of other eye.The doctor indicated that the connection between the syringe and blunt needle felt loose and was tightened.If the patient continues having issues, the patient will be taken outside the facility for further evaluation.

Manufacturer Narrative

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

Event Description

The postoperative visual acuity has not improved as expected.

Manufacturer Narrative

The finished good lot specific to this event is not known; therefore, lot history and device history record review was not possible.The customer reported that the needle shot and came off like a rocket during surgery.There was no patient harm.The customer¿s complaint could not be investigated as the customer did not retain a sample for this complaint report.Without a sample, visual inspection could not be conducted.The supplier conducted a shape test and the result met their quality standard and no other anomalies were observed.They also performed a functionality test on 10 reference samples; no reported event occurred.The supplier was unable to identify a root cause.This is a complaint against a japan component that is import for export.The file will be processed for closure and opened at a later date if a sample is received or additional information is provided by the supplier.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is impossible to isolate the root cause and it is unknown.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.The manufacturer internal reference number is: (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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7174822
• MDR Text Key: 96828397
• Report Number: 1644019-2018-00007
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14132
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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