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

Model Number	SN60AT
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, after implantation of the iol had massive deposits on the upper surface.At first they were practically impossible to remove.Surgeon then turned the cannula and went directly to the lens surface with the suction opening.The deposits could be removed to a large extent.Surgeon is curious how the lens looks next week in mydriasis and whether any residue can be removed with the yag laser.The deposits looked kind of greasy to surgeon.Surgeon added that this would fit because they felt so comfortable on the lens.Surgeon said that where these deposits could have come from is a complete mystery to him - they can't come from the cartridge, since the top is inside the cartridge when it is rolled up.Additional information has been received and stated that continued minor deposits on the iol with increased glare sensitivity.As per the surgeon there was no requirement of medical or surgical intervention.However surgeon also mentioned that possibly later attempt yag polishing.The patient was not hospitalized for the event.

• Brand Name: ACRYSOF 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: 17423100
• Report Number: 9612169-2023-00567
• Device Sequence Number: 15346430
• Product Code: HQL
• UDI-Device Identifier: 00380650130334
• UDI-Public: 00380650130334
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.215
• Device Lot Number: 25578678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III CARTRIDGE C; MONARCH III INJECTOR; PROVISC
• Patient Age: 83 YR
• Patient Sex: Female