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

Model Number	MA60AC
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
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 facility representative reported that during an intraocular lens (iol) implant procedure, they had issues loading a iol and once implanted, the surgeon observed that the iol was inverted and had to be explanted.Additional information was received, stating that due to changes in the procedure surgeon had to do a vitrectomy which involves changing the original lens to a 3 piece lens.Surgeon he needed a 3mm knife, b cartridge and the inserter.Viscoelastic was injected into cartridge and proceeded to load the lens with the alcon lens forceps, seating the lens and wrapping trailing haptic around the post of cartridge.The cartridge was loaded into lens inserter and the plunger was advanced.The plunger of lens inserter didn't advance the lens.Once plunger of the lens inserter advanced the lens.Surgeon checked the lens in the cartridge under the microscope and said everything looked good.Surgeon proceeded to insert the lens into the patients eye.A short time later surgeon said the lens inverted and needed to be retrieved.No other lens was inserted.The patient referred to a retina specialist.

• Brand Name: ACRYSOF MULTIPIECE 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: 18204306
• Report Number: 1119421-2023-01995
• Device Sequence Number: 7373717
• Product Code: HQL
• UDI-Device Identifier: 00380652552479
• UDI-Public: 00380652552479
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2023

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: MA60AC
• Device Catalogue Number: MA60AC.175
• Device Lot Number: 15511097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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 CARTRIDGE B.; MONARCH II INJECTOR.; MONARCH II LOADING FORCEPS.; PROVISC.
• Patient Age: 64 YR
• Patient Sex: Male