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

Model Number	SN6AT7
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse manager reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the lens was mounted on the cartridge in the company injector.At the time of insertion, it was noticed that it was a little harder than normal.Doctor saw this and removed the cartridge from the eye, the lens was seen at the tip of the cartridge which when observed it under a microscope he could see that the cartridge was all open and when removed the lens it was appreciated that the lower haptic was broken.Additional information was received stating procedure was not completed during the surgery and the patient was scheduled for lens implantation in a second surgery.There was no patient harm and patient was not hospitalized as a result of this event.Additional information was received stating patient's lens implantation was performed in a second surgery.Patient was fine and with a very satisfactory recovery.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge with an unspecified handpiece and an non-qualified viscoelastic.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).The viscoelastic indicated is not qualified for the lens/cartridge combination used.The ifu (instructions for use) instructs that a 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.The ifu (instructions for use) instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The carton, inserts and empty lens case were retuned.The lens was not returned for evaluation.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge with an unspecified handpiece and an non-qualified viscoelastic.The root cause for the reported broken haptic may be related to a failure to follow the ifu.The viscoelastic indicated is not qualified for the lens/delivery systemcombination used.The ifu instructs that a 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.Based on review of the returned cartridge, inadequate ovd was observed along with extensive cartridge damage.The ifu instructs to completely fill the cartridge with 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 extensive cartridge damage may indicate damage to the handpiece.This type of damage may occur if the lens/plunger are not in acceptable positions for advancement.The ifu instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.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: 16476390
• Report Number: 1119421-2023-00385
• Device Sequence Number: 7447728
• Product Code: MJP
• UDI-Device Identifier: 00380652275880
• UDI-Public: 00380652275880
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7.180
• Device Lot Number: 15455333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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: HILURON 1.8%; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; MONARCH, INJECTOR, UNSPECIFIED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female