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

Model Number	DFT015
Medical Device Problem Codes	Crack (1135); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during cataract extraction with intraocular lens (iol) implant procedure, there were scratches/cracks at optic edge of the lens noted.Lens was exchanged during same procedure.Additional information has been requested.
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
The lens was returned positioned incorrectly in the lens case.The lens case was inside the opened associated cartridge pouch, placed into the opened lens carton.Viscoelastic was dried on the lens.The lens optic was broken or cut into three portions.One haptic was broken in the distal area.The broken haptic was returned in the lens case.One optic portion has scratches on the posterior surface near the periphery.These type scratches are commonly referred to as "stutter scratches".The associated company cartridge was returned in a small medical device package placed into the opened lens carton.Insufficient viscoelastic was observed inside the cartridge.The cartridge shows evidence of being placed into a handpiece.The cartridge nozzle and tip have stress lines.A qualified handpiece and viscoelastic were indicated as associated products.The reported scratches were observed.The root cause for the reported complaint may be related a failure to follow the instructions for use (ifu).An inadequate amount of viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices 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 scratches resemble "stutter scratches".Stutter scratches typically occur due to a lack of viscoelastic and /or if the lens was delivered too rapidly.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 or delivery issues.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: 13176560
• Report Number: 1119421-2022-00035
• Device Sequence Number: 4664943
• Product Code: POE
• UDI-Device Identifier: 00380652421270
• UDI-Public: 00380652421270
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 11/03/2025
• Device Model Number: DFT015
• Device Lot Number: 15112293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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 D.; MONARCH III INJECTOR.; PROVISC.
• Patient Sex: Unknown