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	02/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The company lens model is only qualified for use in the company cartridges.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A registered nurse reported that during a cataract extraction with an intraocular lens (iol) implant procedure, there was a scratch on lens after implanted.Used lens cutters to remove and replace the lens.Procedure was completed on the same day.Additional information was received stating patient was not hospitalized as a result of this event.
Additional Manufacturer Narrative
The lens and the associated company cartridge were returned loose inside the lens carton.The lens was returned positioned incorrectly inside the lens case.Solution was dried on the lens.One haptic was bent in the gusset and distal area.The other haptic was bent in the gusset area and broken in the distal tip.The lens was cut into two pieces placed one atop the other in the well area of the lens case.The optic was scratched and torn with additional cracked and split areas near the optic edge.An inadequate amount of viscoelastic was observed in the non-qualified cartridge.The wings were not compressed which would indicate the cartridge was not fully seated into a handpiece.A non-qualified cartridge was used.The company lens model is only qualified for use in the company cartridges.Information was provided that a company handpiece and unknown viscoelastic were also used.The root cause was most likely related to a failure to follow the ifu (instructions for use).A non-qualified cartridge was used.An inadequate amount of an unspecified viscoelastic was also observed, and the cartridge did not show evidence of being fully seated into a handpiece.The ifu (instructions for use) instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company recommends using the qualified company intraocular lens delivery system or any other company qualified combination.The ifu (instructions for use) also instructs to completely fill the cartridge with ovd (ophthalmic viscosurgical devices) (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd (ophthalmic viscosurgical devices) in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd (ophthalmic viscosurgical devices), which may result in damage.There is evidence that the cartridge may not have been fully seated in the handpiece.The ifu (instructions for use) instructs the user to insert the cartridge into the handpiece and fully slide the cartridge forward into the handpiece locking slots.This could have also caused the lens to deploy incorrectly or the plunger to be misaligned during advancement, which could result in product damage.The file indicated that the company 24.0 diopter lens was removed and replaced with an identical lens model and diopter.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: 16691594
• Report Number: 1119421-2023-00608
• Device Sequence Number: 17982631
• Product Code: HQL
• UDI-Device Identifier: 00380652555883
• UDI-Public: 00380652555883
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: SA60AT
• Device Catalogue Number: SA60AT.240
• Device Lot Number: 15493935
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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 II FORCEPS; MONARCH III, CARTRIDGE D; MONARCH III, INJECTOR
• Patient Age: 70 YR
• Patient Sex: Female