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

Catalog Number 12354

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

Patient Problems Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888); Hyperemia (1904); Keratitis (1944); Loss of Vision (2139); Eye Pain (4467)

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 red, painful blind right eye, conjunctiva congestion, band keratopathy, silicone oil emulsification, calcification of eye ball, ossification, limbus neovascularization, ocular hemorrhage.An evisceration with subsequently placing an acrylic orbital implant behind the scleral shell was performed.The patient was relieved from pain.

Manufacturer Narrative

Yinhao wang, wei cui, rongjun liu, yanjie tian, wei ni and changlei zhou.Silicone oil¿associated extensive intraocular ossification.European journal of ophthalmology 2021, vol.31(5) np53¿ np56 the author(s) 2020 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/1120672120925785.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The customer did not retain the product lot information for this custom pak, therefore the device history records traceable to the reported procedure pack could not be reviewed.A literature review reported that retention of silicone oil in the eye of a patient most likely accelerated the ossification in the patient's eye.A review of the manufacturing records shows that no vitrectomy pak or viscious fluid control (vfc) device was built into the reported custom pak.A further review of the individual components built into this pak showed that no silicone oil was present on any item built into the finished custom pak.The silicon oil that caused the ossification did not originate from an alcon product that was provided to the customer as part of the reported custom pak.The root cause of the silicon oil that was reported in the literature review is related to an unknown external source.A review of the manufacturing records for the reported custom pak showed that no silicon oil was present in any of the products provided to the customer.No action will be pursued at this time for this occurrence.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.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, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13334233
• MDR Text Key: 284298546
• Report Number: 1644019-2022-00079
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12354
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male