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

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/09/2022

Event Type  malfunction  

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, the abrasion occurred in the cartridge.The abrasion adhered to the back of the iol and could only be removed (aspirated) with difficulty.There are also abrasion marks in the cartridge.There was a patient contact, but patient impact was not known.Additional information has been requested.

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 two other complaints reported in the lot number.Photos were provided.There are two qs records.It is unknown which cartridge qs the photos are for; evaluation will be placed in both files.The first photo is of a lens in the eye.What appears to be linear material is observed.There also appears to be marks on the optic.The haptics are not visible.Unable to determine if the marks are in the travel path.The origin and nature of the material cannot be determined from the photo.The second photo is a side view of a cartridge tip.Viscoelastic is visible.The appear to be damage to the side of the tip.Extent of damage cannot be determined from the photo.The third photo is of the tip of a cartridge.The view is down through the lumen.There appears to be damage to the interior of the tip (left side).The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

In the initial mdr wrong concomitant medication was reported, corrected information provided in d.10.Additional information provided in d.9., h.3., h.6.And h.10.Three used company cartridges were returned in a plastic tray.There was no way to differentiate between the samples for the two reported lot numbers.The evaluations will be placed in the related qs records.The returned unopened company cartridge sample evaluations will be placed in the files for the specific lot returned.Six loose company cartridges were returned in a bag.The six returned loose company cartridges were numbered 1-6 for evaluation purposes.The six returned used company cartridges were microscopically examined and no foreign material was observed.One cartridge exhibited no signs of use.The other 5 cartridge all exhibited a lack of viscoelastic.The five used company cartridge had evidence of placement into a handpiece.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.Internal damage was observed with disruption in the coating on the left side of the tips.The three used company cartridges returned in the tray were numbered 1-3 for evaluation purposes.The three returned used company cartridges were microscopically examined and no foreign material was observed.Two of the used samples has no residual viscoelastic observed.One had a very small amount.All three used cartridges had internal damage to the tip.The three used company cartridges had evidence of placement into a handpiece.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.Internal damage was observed with disruption in the coating on the cartridge tips.Five unopened and one opened 10-count carton were returned for lot.Fifty-eight unopened company cartridge samples were returned.Six of the returned unopened samples were randomly pulled for evaluation (samples were taken from each carton).The company cartridges were numbered 1-6 for evaluation purposes.The six returned unused company cartridges were evaluated.The company cartridges were opened and microscopically examined with no damage observed.No particulate was observed inside the cartridge lumens.All six company cartridges were functionally tested per the ifu.No lens or cartridge damage was observed after the lens deliveries.No foreign material was observed.The company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Photos were provided.The first photo is of a lens in the eye.What appears to be linear material is observed.There also appear to be marks on the optic.The origin and nature of the material cannot be determined from the photo.The second photo is a side view of a cartridge tip.The appears to be damage to the side of the tip.Extent of damage cannot be determined from the photo.An additional photo was provided, which matched the six returned products.Associated products were not provided.It is unknown if qualified products were used.The lenses were indicated to be a mid-diopter range.However, each specific model is qualified for a specific range.The range is not the same across all model lines.The handpiece was not provided.A qualified viscoelastic was indicated.Based on the review of the returned used company cartridges, the reported foreign material may have been internal coating material from the damaged company cartridge tips.Six of the unopened company cartridges returned for the reported lot were evaluated.No foreign material was observed.Functional and dye stain testing was conducted with the unopened samples with acceptable results.No foreign material was observed after the functional testing.The associated lenses were indicated to be a mid-diopter range.The qualified range is not the same across all model lines.Without the specific lens model/diopter and handpiece information it cannot be determined if a qualified combination was used.Per the ifu: the company iol delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.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.In addition, the eight used cartridges did not appear to have adequate ovd.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.There are two other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• 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: 14944792
• MDR Text Key: 295484850
• Report Number: 1119421-2022-01492
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063155
• 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: 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 15374831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IOL; IOL, UNSPECIFIED; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE