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

Catalog Number 8065977763

Device Problems Break (1069); Scratched Material (3020); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There has been one other complaint reported in the lot number.Additional information was requested.A questionnaire was received.(b)(4).

Event Description

A technician reported that a cartridge split.The event occurred prior to the iol touching the eye.A questionnaire was received form the technician who reported there was resistance during implantation and the iol was scratched.There was no patient harm.

Manufacturer Narrative

The cartridge was returned.Only a small amount of solution was observed dried in the cartridge.The tip has heavy stress lines prior to parting line and on the tip.An aneurysm is noted at the parting line which has torn/split completely along the posterior right side.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The associated lens was returned.Viscoelastic was observed on the lens.One haptic is broken at the gusset area (returned) and broken in the distal area (returned adhered to the optic surface).The optic is folded (broken) along one side with additional split/cracked damaged areas.The split/cracked damage may have been interpreted as the reported complaint of scratch.Cartridge product history records were reviewed and the documentation indicated the product met release criteria.A qualified lens was used with the cartridge.The iol product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified handpiece and viscoelastics.The reported tip damage was observed in the cartridge.There was no scratched lens damage observed.Other lens damage was observed, which may have been interpreted as the reported complaint of scratch.The root cause of the complaint may be related to a failure to follow the dfu.An inadequate amount of viscoelastic was observed in the cartridge.The observed tip damage typically occurs if there is an inadequate amount of viscoelastic between the lens and the cartridge lumen or if the lens is not positioned correctly.In addition, if the handpiece plunger is not positioned at the trailing optic edge it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.Top coat dye stain testing was conducted with acceptable results.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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7793595
• MDR Text Key: 117707772
• Report Number: 1119421-2018-01159
• Device Sequence Number: 1
• Product Code: MSS
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32615993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR