MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

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

Patient Problems Foreign Body Sensation in Eye (1869); Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140)

Event Type  Injury  

Event Description

A consumer reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision and the vision is like a string across the lens.The lens was implanted as a preventive measure with intraocular pressure by the surgeon.The blurry vision was not an issue before the procedure.When the patient hold the eye tight or take an unspecified eyedrop the vision clears.The vision through the nasal side of the lens seems like it is not in the right place.The lens feels like a foreign object is there.Additional information has been received from the consumer and stated that consumer had diplopia also.Consumer also stated that, a stent was placed to decrease the iop (intraocular pressure) on (b)(6) 2021.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 15320802
• MDR Text Key: 298889354
• Report Number: 1119421-2022-01871
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093191
• UDI-Public: 00380655093191
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.200
• Device Lot Number: 15167716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: XEN GEL STENT ALLERGAN
• Patient Outcome(s): Required Intervention
• Patient Sex: Male