MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT015
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during cataract surgery with intraocular lens (iol) implant procedure, a scratch was discovered on the iol immediately after implantation.The iol was polished with the irrigation and aspiration handpiece and so the scratch was mitigated.Iol remains in the eye.There was no patient impact reported.Additional information has been requested.
Additional Manufacturer Narrative
The lens was not returned.A video and photo were provided.A narrow linear mark or material was observed.The lens and cartridge preparation were not shown.The lens loading and advancement were not shown.It cannot be determined if the instruction for use (ifu) was followed.A qualified cartridge and handpiece were indicated with a non-qualified viscoelastic.The root cause for the reported issue could not be determined.The lens was not returned for evaluation.Based on the review of the returned used company cartridge (b)(4), the reported scratch may have been internal coating material from the damaged company cartridge tip.A video and photo were provided.A narrow linear mark or material was observed.The lens and cartridge preparation were not shown.The lens loading and advancement were not shown.It cannot be determined if the ifu was followed.The cartridge exhibited insufficient viscoelastic and a non-qualified viscoelastic was indicated.Per the ifu: company foldable iols 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.The ifu also instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION 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: 16335422
• Report Number: 1119421-2023-00269
• Device Sequence Number: 17853714
• Product Code: POE
• UDI-Device Identifier: 00380652421195
• UDI-Public: 00380652421195
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/31/2023

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 Expiration Date: 05/11/2026
• Device Model Number: DFT015
• Device Lot Number: 15201301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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 CARTRIDGE D; MONARCH INJECTOR; VISCO ZEISS Z-CELCOAT DISPERSIVE
• Patient Age: 61 YR
• Patient Sex: Male