MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Glaucoma (1875); Blurred Vision (2137)

Event Date 06/06/2022

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: 2022-54441.

Event Description

A patient reported that there was a surgery to replace the lens.The surgery was difficult, and it took 40 minutes.Following the iol implant procedure, the patient's intraocular pressure (iop) sometimes raises to 30, black flies swim in the eye around the luminous objects of the areola.A preliminary diagnosis was glaucoma.Additional information received and stated that, the patient has foggy vision.The suture was placed during the surgery but the patient was not known the reason for suture.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15474677
• MDR Text Key: 300552510
• Report Number: 9612169-2022-00486
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655095683
• UDI-Public: 00380655095683
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.135
• Device Lot Number: 21285190
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male