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

Model Number	DFT015
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
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 has been one another complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during implantation of an intraocular lens (iol) the lens seemed stuck during placement of the lens, haptic has broken off.Lens has been cut in half for removal and replaced with another lens.Additional information was requested and received stating the wound was enlarged while removing the lens and suture was done.
Additional Manufacturer Narrative
A photo was available in the file.The photo was very blurry.The image was of the lens inside the eye.The optic has large areas that are broken on the edge.The haptic areas cannot be discerned from this image.An instrument was also observed, in the image.Possibly used to aspirate the lens, while in the eye.The areas of optic damage are large and may include the area of one haptic.However, the photo was too blurry for a 100% confirmation of the reported complaint.A non-qualified company cartridge was used.The diopter of the company complaint lens is beyond the qualified range for the company cartridge.A company handpiece was used.A non-qualified viscoelastic was used.Based on the provided photo, the lens optic has large areas of the edge that are broken.It is likely, that the haptic area was included in the observed broken areas.The root cause for the reported complaint was most likely related to a failure to follow the ifu (instructions for use).A non-qualified cartridge and non-qualified viscoelastic were used.The ifu 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 delivery system or any other company qualified combination.The diopter of the company complaint lens is beyond the qualified range for the company cartridge.The company diopter lens is qualified for use in the company with qualified viscoelastic combinations.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: 15084287
• Report Number: 1119421-2022-01599
• Device Sequence Number: 19828024
• Product Code: POE
• UDI-Device Identifier: 00380652421355
• UDI-Public: 00380652421355
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/20/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2026
• Device Model Number: DFT015
• Device Lot Number: 15232778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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; MONARCH III IOL INJECTOR; PROGEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown