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

Catalog Number 8065751468

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

Patient Problems Abscess (1690); Endophthalmitis (1835); Discomfort (2330); Vitrectomy (2643)

Event Date 10/13/2019

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 three days after performing a combined procedure (phacoemulsification/intraocular lens implant/vitrectomy, and anterior macular debridement) on the left eye, the patient felt discomfort and pus was observed.The surgeon indicated the patient had endophthalmitis.The following day, the patient underwent a vitrectomy, vitreous cavity lavage with anterior chamber irrigation procedure.The patient is improving.This is one of three reports for this facility.

Manufacturer Narrative

Additional information provided in h.6., and h.10.As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.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.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.The manufacturer internal reference number is: 2019-94001.

Event Description

Additional information received on 02/01/2020: it was reported a fungal and bacterial smears taken of the eye secretions.The results were no fungi and no bacteria.

Manufacturer Narrative

Additional information provided in b.5., g.1., g.2.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: 9545484
• MDR Text Key: 173558948
• Report Number: 1644019-2020-00015
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751468
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR