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

Model Number	SN60AT
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, the injector slipped the lens and could not be implanted.There was patient contact noted.The procedure was completed with another lens during the initial procedure.There was no patient harm reported.Additional information has been requested.
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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The iol and two company cartridges were returned for analysis and damage was observed to the returned products.Photo was also returned.Iol returned pressed down into well area of iol case base.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and adhered to the optic surface with solution, the other haptic is bent due to being pressed up against a post of the lens case base.The optic is bent and has fibers and particulate.Two used company cartridges also returned.The cartridges were numbered 1-2 for evaluation purposes.#1 used company cartridge: the used company cartridge was microscopically examined.Inadequate viscoelastic was observed.Tip stress was observed.The cartridge had evidence of placement into a handpiece.Top coat dye stain testing was conducted with acceptable results.#2 used company cartridge: the used company cartridges was microscopically examined.Inadequate viscoelastic was observed.Tip stress was observed.The cartridge had evidence of placement into a handpiece.Top coat dye stain testing was conducted with acceptable results.Photo review: returned photo shows iol in lens case and c cartridge.The iol is positioned incorrectly in the iol case, one haptic appears to be broken/torn, the other haptic appears to be deformed.There is a line visible at the nozzle tip entry, which would indicate inadequate amount of viscoelastic in the cartridge.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).Inadequate viscoelastic was observed in the returned used company cartridges.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.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 16860730
• Report Number: 9612169-2023-00336
• Device Sequence Number: 12284402
• Product Code: HQL
• UDI-Device Identifier: 00380650130341
• UDI-Public: 00380650130341
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2023

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.220
• Device Lot Number: 25547228
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 06/26/2023; 07/26/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 07/24/2023; 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III CARTRIDGE C; PROVISC; UNSPECIFIED MONARCH IOL INJECTOR
• Patient Sex: Unknown