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

Model Number	SN6AT4
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that after implanting the intraocular lens (iol) into the patient's eye, it was found that there were sediment on the haptic, which the surgeon could not remove even with surgical instruments.The surgeon considered it to be on the haptic and did not remove it, but was concerned that it would have an impact on the patient in the future.
Additional Manufacturer Narrative
A sample device 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.Photo provided shows an implanted intraocular lens (iol), there appears to be foreign material present on the haptic.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Photo shows implanted intraocular lens (iol).Imperfection on the haptic tip is observed.It is not clear from the photo if the imperfection is related to a foreign material or damage (niched/ chipped) to the haptic tip.Based on our observation of the attached photo, one haptic shows defect.The observed defect may be related to a nicked/ chipped haptic tip.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17135664
• Report Number: 9612169-2023-00455
• Device Sequence Number: 12205799
• Product Code: MJP
• UDI-Device Identifier: 00380652250429
• UDI-Public: 00380652250429
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: SN6AT4
• Device Catalogue Number: SN6AT4.200
• Device Lot Number: 25537038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 08/13/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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
• Patient Sex: Unknown