MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977763

Device Problem Crack (1135)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

Three used company cartridges were returned for the four reported complaints; one was indicated as discarded.There is no way to identify which cartridge was used with which patient.The evaluations will be placed in all four files.Four unopened company cartridges were also returned for the reported lot number.One was pulled randomly for evaluation.All three returned used company cartridges were microscopically examined.Inadequate viscoelastic was observed in all three cartridges.All three cartridge nozzles were cracked along the top.One crack was larger than the other two.As the cracked areas traveled into the thinner cartridge tips the material split to the end of the top.All three tips exhibited heavy stress.The used company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.One unopened company cartridge was evaluated.The unopened company cartridge was microscopically examined with no damage or abnormalities observed.The cartridge was functionally tested.No lens or cartridge damage was observed after the lens delivery.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens model/diopter, handpiece and viscoelastic were indicated.It was also indicated that viscoelastic and balanced salt solution (bss) were used in the cartridges.This is not per the instructions for use (ifu).The root cause for the observed cartridge damage may be related to a failure to follow the ifu.Inadequate viscoelastic was observed in the returned used cartridges.It was indicated that viscoelastic an bss were used in cartridges.This is not per the ifu.The returned used company cartridges all had cracks which started in the nozzle and extended into splits in the thinner cartridge tips.Heavy stress was also observed.The damage on the top of the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.Damage in the thick cone wall section has been associated with the use of cold viscoelastic.The ifu instructs to use viscoelastic, which has been allowed to come to the operating room temperature.This type of damage may also occur if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece.Inadequate viscoelastic was observed.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices (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.One unopened company cartridge was evaluated.The company cartridge was functionally tested per the ifu.No lens or cartridge damage was observed after the lens delivery.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).

Event Description

A health care professional reported that during an intraocular lens (iol) implant procedure, cartridge cracked while the lens was being implanted and there was no patient harm.As per the surgeons opinion impact to the nozzle was due to stress fracture.

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• 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: 19058329
• MDR Text Key: 339608033
• Report Number: 1119421-2024-00650
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2024

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 Catalogue Number: 8065977763
• Device Lot Number: 15766061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BSS STERILE IRRIGATING SOLUTION.; CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL.; MONARCH II LOADING FORCEPS.; MONARCH III INJECTOR.; PROVISC.
• Patient Age: 84 YR
• Patient Sex: Male