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

Model Number	SA60AT
Medical Device Problem Codes	Defective Component (2292); Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An ophthalmologist reported that during an intraocular lens (iol) implant procedure, encountered iol cannot get out of the cartridge, the iol is too hard.The iol was removed and replaced with another lens during the initial procedure.Additional information was requested.
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 manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in the tip of a non-qualified cartridge.Viscoelastic is observed in the cartridge.The lens is torn/crushed into pieces.The cartridge tip has heavy stress and is torn on the bottom and split on top.It appears the plunger was advanced under the lens and through the bottom of the cartridge.The cartridge was cleaned for further evaluation.The lens pieces were removed with cleaning.Top coat dye stain testing was conducted with acceptable results.Qualified handpiece was indicated.Viscoelastic was not provided.It is unknown if a qualified product was used.The company lens model is only qualified for use in the cartridges.The lens was returned in the cartridge advanced into the tip.The lens was not implanted and removed as reported.The root cause for the reported issue may be related to a failure to follow the instructions for use (ifu).The lens was returned in a cartridge.Extensive cartridge tip damage was observed.Based on the observed damage a plunger underride occurred.Top coat dye stain testing was conducted with acceptable results.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received there was patient contact but no patient harm.The product was single-used.

• 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: 15191887
• Report Number: 1119421-2022-01742
• Device Sequence Number: 5914861
• Product Code: HQL
• UDI-Device Identifier: 00380652555814
• UDI-Public: 00380652555814
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Report Date (Section B): 12/09/2022

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.205
• Device Lot Number: 15302001
• 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: 07/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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, CARTRIDGE C; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; MONARCH III IOL, INJECTOR
• Patient Sex: Unknown