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 Problem Break (1069)

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

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The iol product history records were reviewed and documentation indicates the product met release criteria.Root cause has not been identified.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol)implant procedure, a lens with a broken haptic was inserted into the patient's eye and had to be removed and replaced with a back up lens.The surgeon indicated to the nurse that during the injection, there was some tension.The plunger of the hand piece was also reported as over riding the lens.Additional information was requested.There are two medical device reports associated with this event.This is the report for the cartridge.

Manufacturer Narrative

The cartridge was returned.Viscoelastic was observed inside the cartridge.The wings of the cartridge tabs show uneven pressure marks.No lens was returned.The customer indicated the use of a qualified lens model, a qualified handpiece and viscoelastic.Iol product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause cannot be determined for the complaint of "tension when advancing lens; haptic broken in the cartridge".There was no damaged lens present in the returned cartridge.The root cause of the reported complaint may be related to a failure to follow the dfu.The dfu instructs the user to fully seat the cartridge into the handpiece.Evidence was observed of uneven pressure marks on the cartridge tabs.This may indicate that the cartridge was not fully seated inside the handpiece locking slots.If the cartridge was not seated correctly inside the locking slots of the handpiece, the handpiece plunger would not have been aligned properly to deliver the lens correctly, which may result in damage to the product.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: 7668723
• MDR Text Key: 113634605
• Report Number: 1119421-2018-00870
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2018
• 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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 63 YR