MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751763

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

Patient Problems Bacterial Infection (1735); Endophthalmitis (1835); Unspecified Infection (1930); Loss of Vision (2139)

Event Date 08/08/2019

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 surgeon reported a patient experienced pseudomonas endophthalmitis after a cataract extraction procedure with intraocular lens implant.The patient has had a loss of vision in the infected eye.The surgeon is wondering if the germ could have come from the water.All ophthalmic surgeries have been stopped.Additional information has been requested but no received.

Event Description

Additional information has been received neither the surgeon or the hospital believe that any company product caused or contributed to the event.They believe the cause was related to the elevated temperature in the operating room.

Manufacturer Narrative

Additional information has been provided in event.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The system is a closed system.It is operated with a sterile single use consumable cassette, which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (phaco handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).The phaco handpiece is a reusable device that must be reprocessed per the product dfu.There is no evidence that the design or performance of the centurion caused or contributed to this reported event of endophthalmitis.Quality consumer affairs called the customer to discuss on going issues and the reported event with this incidence.It was determined during the facility investigation that there was an issue with air or gas humidity in the room.The customer described it as hygrometric issue and that the humidity was too high, potentially altering the sterility of the consumable boxes.It was discovered that the customer attributes the event to temperature changes.As such, ophthalmic cases were temporarily stopped.They have since resumed all cases, without further reoccurrences.There was no information provided to determine what variables may have changes during the temporary shutdown of ophthalmic cases.The customer did convey, however; that they are unwilling to provided further feedback on the event at this time.There was no new information on the patients with the reported 'severe post-operative infection.' follow-up information stated that neither the surgeon nor the hospital believe that any of the manufacturers product caused or contributed to the reported event.They believe the cause was elevated temperature in the operating room (or).Additionally, the surgeon and hospital remain confident in the manufacture's products.The customer did not request service for the system.The system serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.No cassette sample has been returned for evaluation; therefore, the condition of the product could not be verified.The lot complaint history was reviewed; this is the first complaint for the finish goods lot number and first for this issue for this lot number.The device history record shows the product was released per specifications.All procedure paks are single-use devices provided to the customer in a sterile manner.No custom pak was received for evaluation.The device history review (dhr) review did not show any abnormalities.No remarks were made during the manufacturing process of this lot.There were no quality remarks documented.No non-conformances were documented during the sterilization process.Custom paks are manufactured in a controlled environment.Dress code and hygienic procedures are in place in order to prevent the risk of contamination.These procedures are checked on a regular basis by qa through in process audits.No other complaints for endophthalmitis were received for custom paks sterilized in the same sterilization cycle.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Event Description

Corrected information has been received the patient was hospitalized for this event from (b)(6) 2019.

Manufacturer Narrative

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

Event Description

Additional information has been received indicating the surgeon could not tell what product was suspected since they had an hygrometric issue in the operating room: it was too high and it could have altered sterility of the boxes.Therefore, they have reported this incident by precaution but the hygrometric issue may have been the cause of the infection.The surgeon could not specify what product inside the custom pak was suspected.The current patient condition is currently unknown.A completed questionnaire has been received from the surgeon.No preoperative medications or antibiotic drops were used.The wound was intact.The intraocular lens was implanted in the capsular bag.No sutures were required.The patient presented with corneal edema, retinal edema, vitritis, decrease in intraocular pressure and hypopyon.The patient was hospitalized for this event from (b)(6) 2019.The patient was on anti-depressant medications at the time of the reported event.The patient required intravitreal injections of antibiotics.The patients symptoms persist and prognosis is not good.

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8940403
• MDR Text Key: 155848910
• Report Number: 2028159-2019-01573
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF IOL; ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT SYSTEM; APROKAM; BALANCED SALT SOLUTION (BSS); BETADINE PREP; CEN FMS PACK,ACT,.9U 30 BAL; CUSTOM-PAK SURGICAL PROCEDURE PACK; VISTHESIA 1,5%; ACRYSOF IOL; CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Outcome(s): Hospitalization; Other; Required Intervention