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	Corneal Edema (1791)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during implantation of an intraocular lens (iol) the lens had a defect, it had a scratch in the central part of the optic.For this reason, he proceeded to extract it, report it as a quality complaint and implanted another lens.There was a 15 minute delay but the procedure was completed, patient is fine, only with a little corneal edema and the patient was recovered.Additional information was requested and received stating patient was recovered and the corneal edema has disappeared.
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).
Additional Manufacturer Narrative
A photo was provided of a lens in the eye.One haptic was shown on the anterior optic surface at the time of photo.A portion of the other haptic can be observed at the far left of the photo.The entire lengths of the haptics are not possible to be viewed in this photo.A dark linear shadowy line was observed at the optic center.It cannot be confirmed from the photo if this shadowy area is a scratch or cracked damage.A qualified cartridge, unspecified company handpiece, and a qualified viscoelastic were indicated.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: 15750056
• Report Number: 1119421-2022-02370
• Device Sequence Number: 11502701
• Product Code: POE
• UDI-Device Identifier: 00380652421317
• UDI-Public: 00380652421317
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 08/24/2026
• Device Model Number: DFT015
• Device Lot Number: 15257783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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 DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; PROVISC; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown