MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT4
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/30/2022
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 two other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A procedure manager reported that, during intraocular lens (iol) implant procedure, the incision was enlarged slightly and inserted into the eye, whilst injecting the iol into the eye the trailing haptic was torn from the optic.The surgeon then cut the iol out and asked for the backup lens.The surgeon asked for a cartridge and a blunt probe to push the iol down the cartridge and into the eye.Unfortunately, during insertion of the iol, the posterior capsule ruptured and an anterior vitrectomy was performed the procedure was completed and the patient was left without a lens implant with a view to return for a secondary lens implant at a later date.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned.Information was provided that a non-company delivery system and viscoelastic were used.Based on the information provided, the root cause for the reported events is related to a failure to follow the instructions for use (ifu).Information was provided by the surgeon that by the time they were operating on the final patient of the day, they had used all of the company preferred injectors and only had a non-company disposable injector left to use.The non-company injector severed the haptic resulting in the surgeon removing the lens and inserting the standby lens.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 manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 14336660
• Report Number: 1119421-2022-00974
• Device Sequence Number: 5337303
• Product Code: MJP
• UDI-Device Identifier: 00380652250603
• UDI-Public: 00380652250603
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/19/2022

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: 10/02/2026
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.290
• Device Lot Number: 15278237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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: B&L INJECTOR; HEALONID; MONARCH III IOL CARTRIDGE C
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male