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

Model Number ASKU

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

Patient Problems Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Ptosis (2620); Eye Pain (4467)

Event Type  Injury  

Event Description

A customer reported that following an intraocular lens (iol) implant procedure, she experienced droopy eyelid, pain.She had dry eyes and used drops with no help.She has taken a second opinion and was stated that her eyelids stretched and need eyelid lifts.There are two medical device reports associated with this patient.This report is associated with the left eye.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.(b)(4).

Manufacturer Narrative

Correction information was provided in h.6 on initial mdr the patient event code of 1814 was added in error.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received stating that she still had dry eye and the patient's vision is good but always felt like something in it.She used 3 types of drops with no results and constantly blinking to get a clear vision.

• Brand Name: IOL, UNSPECIFIED
• Type of Device: UNK
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13667764
• MDR Text Key: 286581142
• Report Number: 1119421-2022-00401
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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
• Date Manufacturer Received: 07/12/2022
• 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): Required Intervention
• Patient Sex: Female