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

Model Number	DFT615
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during implantation of an intraocular lens (iol) a crack was noticed on the iol after implantation.The iol was explanted and back up iol used to complete the surgery.Additional information was requested.
Additional Manufacturer Narrative
The explanted lens and the associated company cartridge were returned inside a small specimen jar, along with the opened lens carton.The lens was cut into two portions through the optic.Each half contains a full haptic.One haptic was chipped on the outer distal edge.One optic portion was chipped and has linear cracks on the anterior and directly opposite on the posterior in the shape of an instrument used to grasp the lens.The posterior of the other optic portion has a long scratch near the periphery.An abundance of ovd(ophthalmic viscosurgical devices) still within the body of the cartridge.The cartridge tip has stress lines past the parting line.The cartridge wings displayed evidence of being placed into a handpiece.Product history records were reviewed and the documentation indicated the product met release criteria.The handpiece and viscoelastic product information was not provided.It is unknown if qualified products were used.The explanted lens and associated cartridge were returned.The root cause cannot be determined for the reported complaint.The reported crack damage was observed on the optic.Additional lens damage was observed.The optic was cut into two pieces, typical of damage created to facilitate a removal from the eye.It is unknown if a qualified handpiece and viscoelastic were used with the qualified lens/cartridge combination.The ifu(instructions for use) 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.Company recommends using the qualified company iol(intra ocular lens) delivery system or any other company qualified combination.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC 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: 14517582
• Report Number: 1119421-2022-01138
• Device Sequence Number: 6531262
• Product Code: POE
• UDI-Device Identifier: 00380652423342
• UDI-Public: 00380652423342
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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 Expiration Date: 04/05/2026
• Device Model Number: DFT615
• Device Lot Number: 15183375
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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 D
• Patient Sex: Unknown