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 Vitreous Floaters (1866); Visual Disturbances (2140)

Event Type  Injury  

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

Event Description

A consumer reported that following an intraocular lens (iol) implant procedure, the patient could not see well immediately after surgery.The patient had laser surgery after months of the surgery.After one and half year, the patient had vision like cataract and patient started to wear reading glasses and still can't see to do anything requiring fine motor skills.The patient had decent distance that is blurred in certain spots, but, when evaluated together and could not see clearly.No more information available.There are two medical device reports associated with this patient.This report is associated with the right eye.

• 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: 14460474
• MDR Text Key: 292224601
• Report Number: 1119421-2022-01073
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• 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
• Report Date: 05/20/2022

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
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/20/2022
• 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