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

Model Number	SA60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A non healthcare professional reported during an intraocular lens (iol) implant procedure, the surgeon saw a gash in the optic after it unfolded and the lens was taken out in the initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned.All product and batch history records are quality reviewed prior to product release.Associated products were not provided.It is unknown if qualified products were used.The root cause for the removal of the iol could not be determined.A malfunction has not been indicated against the lens.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
It is unknown if a qualified viscoelastic was used with the qualified lens/cartridge/handpiece combination.The ifu 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.The company recommends using the qualified delivery system or any other company qualified combination.Corrected information was provided in d.10.- concomitant product cartridge updated and in h.10.- in initial mdr, incorrect statement was provided "associated products were not provided.It is unknown if qualified products were used." which should be "information was provided that indicated the use of a qualified cartridge and handpiece" the manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 12917302
• Report Number: 1119421-2021-02288
• Device Sequence Number: 5657585
• Product Code: HQL
• UDI-Device Identifier: 00380652332620
• UDI-Public: 00380652332620
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 12/30/2021

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 Expiration Date: 11/09/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.180
• Device Lot Number: 15113514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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 CARTRIDGE B; MONARCH II IOL DELIVERY SYSTEM,; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Age: 76 YR
• Patient Sex: Male