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

Catalog Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem Toxicity (2333)

Event Date 03/15/2016

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 customer reported one case of suspected toxic anterior segment syndrome.Additional information and product sample have been requested.No updates have been received at this time.

Manufacturer Narrative

The clinical analyst has reviewed this file and stated the following ¿the surgeon had a case of suspected toxic anterior segment syndrome (tass).They are not sure as to what product might be the contributing factor.The most common causes of tass are identified as follows in order of prevalence: inadequate flushing of phaco, irrigation/aspiration handpieces and cannulated equipment, use of enzymatic cleaners and detergents, use of reusable cannulas, inadequate cleaning of instruments, use of preserved epinephrine, reuse of single use devices, use of tap water with no sterile water final rinse, inadequate personnel or trays to allow proper preparation of instruments, no immediate cleaning allowing ophthalmic viscoelastic device (ovd) and surgical solutions to dry on instruments, use of preserved medicines in the eye, reuse of tubing for flushing, latex bulbs for irrigation, not training, no terminal sterilization, instruments stored on towels, touching of iol or patient contact areas of instruments with gloved hands, off-label use of lidocaine gel, poor instrument maintenance, autoclave residue, rust, particulates, lint, use of powdered gloves, additives added to balanced salt solution against directions for use (dfu) , improper use of prep solutions, detergents and cleaners, failure to follow manufacturer¿s directions for use, including no air flush, use of unapproved enzymatic cleaners, use of postoperative ointment in clear corneal cases, povidone-iodine placed in the eye at the end of procedures, incorrect concentration of detergents and enzymatic cleaners.The phacoemulsification systems are closed systems.They are operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any surgical instrumentation that would come into contact with the patient would be cleaned and autoclaved by the user prior to surgery, per standard industry practices and company directions for use (dfu).The proper cleaning and sterilization of ophthalmic surgical instruments can help prevent the occurrence of tass.These findings continue to validate the need to follow the recommendations detailed in the dfus, aorn recommended practices, and the ascrs tass task force guidance document.There is no evidence that the design or manufacturing of the system or the handpiece contributed to the reported event.¿ product evaluation: no further information was able to be obtained from this customer.However, the company sales representative stated the facility no longer suspects our products contributed to the event.The consumable pack, which is lot specific to this event, is not known.Therefore, lot history and device history record (dhr) reviews are not possible.Prior to release of all pack lots, sterilization cycle parameters are verified for acceptability.The root cause of the customer's complaint is not known; a sample was not returned for investigation.With the information available to date, no evidence exists to suggest the pack contributed to the reported event.All batches are released according to the required specifications.A lot code would be required for review of the complaint history and further evaluation.To date no complaint samples viscoelastic have been returned for evaluation.As no sample was returned and no manufacturing related issues were identified, a conclusive root cause could not be determined.Based on and internal investigation, it was advised to have an external consultant visit the concerning hospital for analysis and advise on preventive measures.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.As no product is returned and/or insufficient product data is available, the complaint could not be verified.However, further trending is performed.The hospital found the help from the consultant very helpful and did not have any tass since the consultants¿ visit, after making a few technique changes.No sample or consumable pak, lot information was returned by the customer.Therefore, lot specific evaluation cannot be completed.All compounding, preprocessing, filling and packaging are subjected to 2 independent reviews.All chemistry and microbial finished product results; environmental, utility, bioburden records, and sanitization records.A single, normal level particulate iba inspection and a level i iba is performed for every lot manufactured.This product is terminally sterilized and all sterilization cycles are reviewed before product is released.Surgical technique and product handling and storage are unknown.Potential root causes that could be associated with the complaint condition include: off label use, poor surgical practice, events outside of company control (e.G.Surgical environment / product use), product contamination due to production environment, product formulation stability data.The root cause could not be determined.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.However, the hospital found the help from the consultant very helpful and did not have any tass since the consultants¿ visit, after making a few technique changes.(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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5551556
• MDR Text Key: 41996621
• Report Number: 1644019-2016-00638
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• 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