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 Macular Edema (1822); Loss of Vision (2139); Vitreous Detachment (2445)

Event Type  Injury  

Event Description

A patient reported that, two days following an intraocular lens (iol) implant procedure, he/she developed vitreo macular traction.Following this a vitrectomy was performed.Then the patient had developed cystic macular edema to an extend of blindness.Since then, the patient has been put on a course of steroid drops to reduce the edema.That's helped but not as much as expected.The consumer was unwilling to provide further information.

Manufacturer Narrative

A sample device was not returned for analysis.The product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

• 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: 14888170
• MDR Text Key: 295141414
• Report Number: 1119421-2022-01442
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• 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: 06/08/2022
• 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; Required Intervention