MAUDE Adverse Event Report: ALCON - HOUSTON CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

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

Patient Problems Corneal Edema (1791); Inflammation (1932); Vitritis (2181)

Event Date 12/11/2014

Event Type  Injury  

Event Description

A nurse reported that two days after a cataract with iol (intraocular lens) implantation procedure on the right eye, a patient presented with corneal edema and vitritis which the surgeon associated with fibrin tass (toxic anterior segment syndrome) or early onset endophthalmitis.A tap with culture was performed and the patient received antibiotic injections.The patient was also given a topical steroid every hour and a topical antibiotic four times daily postoperatively.The patient's vision was noted to be improving with a "good" prognosis.No samples are expected to be returned for this report.Upon follow up it was informed that the tap culture was negative.There are no additional details available.This is the first of three reports from this facility for the same event.This report is for the consumable pack.

Manufacturer Narrative

The customer's complaint history was reviewed for the period of one year; this is the first complaint reported for this issue.This is the first complaint reported for this custom pak lot.Review of the device history record indicates the order was built to specification.Review of the sterilization batch records found no deviations; all parameters were met and the batch was released per specification.The customer did not retain a sample for this complaint, as such a full evaluation could not be completed.The root cause of the customer's complaint is not known; a sample was not returned for investigation.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: janet moran ; 6201 south freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4420520
• MDR Text Key: 22163801
• Report Number: 1644019-2015-00005
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2017
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 1660934H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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
• Treatment: PRED FORTE; INFINITI VISION SYSTEM; DUOVISC; ALCON LENS LOADER; BALANCED SALT SOLUTION; POLYTRIM; LIDOCAINE GEL; BETADINE PREP; SN60WF IOL (22.0 DIOPTER); MONARCH "D" CARTRIDGE; INTRACAMERAL LIDOCAINE
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 84