MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MN60AC

Device Problem Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A health care professional reported that during an intraocular lens (iol) implant procedure, it was observed that there was a scratch on the lens.There was no effect on the visual acuity and the lens was retained in the patient's eye.

Manufacturer Narrative

The product was not returned.Two slit lamp photos were provided.The photos were taken off of a computer monitor screen.The first photo was reported to have been taken at day one postop.This photo was of the eye.The lens edges were not visible in this photo.A scratch was not discernable in this photo.The second photo was reported to have been taken at day three postop.This was a close-up photo of the pupil area.An anomaly was observed at the top of the pupil area, 1 o¿clock position.It cannot be determined if this was above or on the lens surface.The haptics were not visible.Unable to determine the orientation of the lens.It cannot be determined if this area was lens damage or organic matter from the eye.A video was provided.The lens was slowly advanced into the eye.The lens unfolded and was rotated with a metal instrument.No lens damage was observed.The pictured anomaly from the day 3-day post visit was not observed on the lens or in the eye.The video ended.Product history records were reviewed and documentation indicated the product met release criteria.A non-qualified cartridge and viscoelastic were indicated with a qualified handpiece.The reported scratch could not be verified.The reported scratch was not observed on the video of the lens delivery or at the day one post-op visit photo.The issue was not observed until the day three post-op visit.It could be determined if this area was lens damage or organic matter from the eye.If this was lens damage the root cause may be related to a failure to follow the ifu.A non-qualified cartridge and viscoelastic were indicated.The company lens model is only qualified for use with the company model ii (a) and ii (b) cartridges.The instructions for use (ifu) instructs: company foldable (intra ocular lens) iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.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.The ifu instructs to completely fill the cartridge with a qualified 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 manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: 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: 18928555
• MDR Text Key: 337950300
• Report Number: 1119421-2024-00517
• Device Sequence Number: 1
• Product Code: HQL
• 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
• Report Date: 05/27/2024

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
• Device Operator: Health Professional
• Device Model Number: MN60AC
• Device Catalogue Number: MN60ACQ230
• Device Lot Number: 15165878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; OPEGAN-HI.