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 Intraocular Pressure Increased (1937); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)

Event Date 11/15/2021

Event Type  Injury  

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).

Event Description

A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced increase in intra ocular pressure from uveitis glaucoma hyphema syndrome.The patient gone through multiple paracentesis to decrease iop.The iol was exchanged in a secondary procedure for different company lens.The surgeon prognosis was uveitis glaucoma hyphema syndrome with iris transillumination.The patient issue has been resolved.No further information available.

• 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: 14208604
• MDR Text Key: 290075351
• Report Number: 1119421-2022-00855
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093269
• UDI-Public: 00380655093269
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• 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.235
• Device Lot Number: 15225048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male