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

Model Number SA60AT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Eye Injury (1845)

Event Type  Injury  

Event Description

A non-health care professional reported during the intraocular lens implantation they were unable to successfully load the lens into the cartridge.The lens was final loaded using the long angle forceps.Then the injector probe kept passing over or under the iol without advancing it.The injector plunger was slightly bent up.The lens was inspected and there were no scratches on the lens.So they enlarged the corneal incision to about 6mm, and manually delivered the lens into the anterior chamber.Then closed the incision with 3 interrupted 10-0 nylon sutures.

Manufacturer Narrative

The product was not returned for analysis; the lens remains implanted.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 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: 16598450
• MDR Text Key: 311843612
• Report Number: 1119421-2023-00520
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380650141309
• UDI-Public: 00380650141309
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.340
• Device Lot Number: 15343729
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LONG-ANGLED MCPHERSON FORCEPS; MONARCH II IOL CARTRIDGE B; MONARCH III IOL INJECTOR
• Patient Outcome(s): Required Intervention