MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON IOL, UNSPECIFIED

Model Number ASKU

Device Problem Patient-Device Incompatibility (2682)

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Dizziness (2194); Reaction (2414)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: complaint history and product history record could not be reviewed because the consumer did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that following bilateral cataract extraction with intraocular lens (iol) implant procedures, she started feeling nauseous, dizzy, and experienced increased blood pressure.She thought she was having a systemic reaction to the eye drops but they¿ve been discontinued for more than one month now, and she is still having those symptoms.She has not been able to drive or return to work.She had lab work done which was normal.She is wondering if she is not tolerating the iol.There are two medical device reports associated with this patient.This report is for the right eye.

• Brand Name: IOL, UNSPECIFIED
• Type of Device: UNK
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7337729
• MDR Text Key: 102343315
• Report Number: 1119421-2018-00273
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OFLOXACIN OPHTH SOLN; PREDNISOLONE OPHTH SUSP
• Patient Outcome(s): Other
• Patient Age: 64 YR