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

Model Number	SN60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Glaucoma (1875); Blurred Vision (2137)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9612169-2022-00486
• Device Sequence Number: 2892588
• Product Code: HQL
• UDI-Device Identifier: 00380655095683
• UDI-Public: 00380655095683
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.135
• Device Lot Number: 21285190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male