MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported with the description of scratches on the intraocular lens.Additional information was received, the surgical tech loaded the company lens 20.0 d into the cartridge with company pusher.The lens went in and there were scratches on top of lens, had to cut lens and take them out of the eye and change into new lens of same diopter and model.
Additional Manufacturer Narrative
A product 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
Correction data was provided in d.4.Additional information was provided in h.3.,h.6 and h.11.The account indicated the use of a non-qualified cartridge.The company lens model is only qualified for use with the company ii (a) or ii (b) cartridges.A qualified handpiece was indicated.Two viscoelastics were indicated, only one is qualified with this lens.It is unknown which one was used in the cartridge.The root cause is most likely related to a failure to follow the ifu (instructions for use).The account used non-qualified cartridge.The company lens model is only qualified for use with the company ii (a) or ii (b) cartridges.Company foldable iols (intra ocular lens) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Information was provided that the lens was scratch on the top.Damage to the anterior surface may occur if there is a plunger override.The handpiece ifu instructs: important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.Verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately half turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The product has not been received to evaluate.File will be reopened if new information or the product is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20371610
• Report Number: 1119421-2024-01952
• Device Sequence Number: 3889408
• Product Code: HQL
• UDI-Device Identifier: 00380652555807
• UDI-Public: (01)00380652555807(17)280926(11)230929(10)15723691(21)15723691078
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2024

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: SA60AT
• Device Catalogue Number: SA60AT.200
• Device Lot Number: 15723691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/28/2024
• Date Device Manufactured: 09/29/2023
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED FORECEPS; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown