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

Model Number SN6AT5

Device Problems Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  malfunction  

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.A photo was provided of the eye.Tow areas are indicated.A line/mark can be observed.Due to the quality of the photo no other determination can be made.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during implantation of an intraocular lens (iol) the foreign material like two streaks entered the optic during iol insertion and the long streak was removed by irrigation/aspiration on the backside, but left scars.The surgery was completed without product replacement.The sample is not available for return.At the next day's examination, it was confirmed that there was no effect on the patient.Additional information was requested.

Manufacturer Narrative

A video was provided.The lens and cartridge preparation were not shown.The company cartridge was brought into view with the lens already inserted into the loading area.The lens was rapidly advanced with the loading forceps.The cartridge was bought back into view after being placed into a handpiece.The lens could be observed at mid-nozzle.Both haptics were tucked in the optic fold.The lens was rapidly advanced into the eye with a non-company handpiece.As the lens unfolded, a long linear mark/material could be observed on the posterior surface of the optic.A shorter parallel mark/material was also observed to the right.Both areas were removed with the irrigation/aspiration tip.The lens remains implanted.The provide photo match the video.A qualified cartridge was indicated.A non-qualified handpiece and viscoelastic were indicated.The product investigation could not identify a root cause for the reported complaint.The product and linear material were not returned for evaluation.No determination can be made without physical evaluation of the complaint sample.A non-qualified handpiece and viscoelastic were indicated.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 foldable iol(intraocular lens)s are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs to completely fill the cartridge with ovd (diagram provided) 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 manufacturer internal reference number is: (b)(4).

Event Description

Additional information was requested and received stating the surgeon decided that medical follow-up was completed since postoperative condition was stable.

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is:(b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: 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: 15120127
• MDR Text Key: 296767922
• Report Number: 1119421-2022-01651
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5A190
• Device Lot Number: 12748150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASICO INJECTOR; HEALON; MONARCH III IOL CARTRIDGE D