MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number ASKU

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

Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Hyperemia (1904); Hypopyon (1913); Inflammation (1932); Optical Nerve Damage (1986); Blurred Vision (2137); Eye Pain (4467)

Event Date 03/12/2021

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 a patient developed endophthalmitis of the left eye with blurred vision, eye pain, hyperemia, lens fibrin, corneal swelling, hypopyon, and inflammation, three days following a vitrectomy with vitreous cavity tamponade with perfluoroorganic compounds (pfos), replacement for silicone oil, and endolaser coagulation (elks) for a subtotal retinal detachment.This same day, the patient underwent a revision of the vitreous cavity with removal of the silicone oil, tamponade of the vitreous cavity was performed with (pfos), phacoemulsification with an intraocular lens implant, and intravitreal administration of antibiotics.Thirteen days following the initial procedure, the patient underwent revision of the vitreous cavity with removal of the pfos, the vitreous cavity was tamponade with silicone oil.The patient was discharged two days later in satisfactory condition.From fifty-one days to fifty-nine days after the initial procedure, a conservative treatment of optic nerve atrophy was carried out with positive dynamics and vision improved.

Manufacturer Narrative

The lot complaint history and device history record (dhr) were not reviewed as no lot information was available for this complaint.The sample was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample will be evaluated.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the 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.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11953763
• MDR Text Key: 254862104
• Report Number: 1644019-2021-00389
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEFTAZIDIME 2.25MG; OXANE 5700; VANCOMYCIN 1MG; CEFTAZIDIME 2.25MG; OXANE 5700; VANCOMYCIN 1MG
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR