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

Model Number	SN6AT3
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
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 nurse reported that during intraocular lens iol implantation procedure, cracks noted at iol when loading into cartridge.There was patient contact but no patient harm.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.The lens was returned advanced just past the loading area in a qualified company cartridge.Inadequate viscoelastic was observed in the cartridge.Viscoelastic was observed in the cartridge tip.A small amount of viscoelastic was observed on the lens.No lens damage can be observed with the lens in the cartridge.The cartridge did not have evidence it was fully seated in the handpiece.The company cartridge was cleaned for further evaluation.The lens was removed during cleaning (placed in lens case).Top coat dye stain testing was conducted with acceptable results.The lens was evaluated.The lens is returned in the lens case.The optic area is scratched/marked - rejectable.The root cause for the reported complaint may be related to a failure to follow the ifu.Inadequate viscoelastic was observed in the cartridge.The ifu instructs: the ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.In addition to this, the cartridge did not have evidence it was fully seated in the handpiece.If the lens was advanced without the cartridge being securely seated into a qualified handpiece, this can allow the handpiece plunger to enter the loading area incorrectly, resulting in lens delivery difficulty or damage.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9.And d.10.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: 16730986
• Report Number: 9612169-2023-00284
• Device Sequence Number: 12440029
• Product Code: MJP
• UDI-Device Identifier: 00380652249980
• UDI-Public: 00380652249980
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2023

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 Expiration Date: 06/30/2024
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.245
• Device Lot Number: 21251310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 06/26/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/20/2023; 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2019
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Sex: Unknown