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

Catalog Number 8065977758

Device Problems Break (1069); Sticking (1597)

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

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.The product history records were reviewed and documentation indicates the product met release criteria.Iol product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.There are no other complaints in the lot.Additional information was requested.(b)(4).

Event Description

A pharmacist reported that when a surgeon was implanting an intraocular lens (iol) it became stuck in the cartridge and became broken.The surgery was then completed without an iol.Lens placement was rescheduled for another time.Additional information was requested.

Manufacturer Narrative

The used cartridge and the lens were returned.Viscoelastic is observed in the cartridge.A haptic is observed at the nozzle entry area.The cartridge has no evidence of being placed into a handpiece.The lens was evaluated.One haptic is pulled from the optic ( in cartridge).The optic is split in the haptic insertion area for this haptic.The second haptic is bent-gusset area.The optic is torn in the haptic insertion area of the bent haptic.The optic is also cut into two pieces.The cartridge was cleaned for further evaluation.Top coat dye stain testing was acceptable.Monarch product history records were reviewed and the documentation indicated the product met release criteria.The lens optic dimensions match the associated lens.The iol product history records could not be reviewed because the facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause for the reported event cannot be determined.The lens was not returned inside the cartridge.The lens was damaged.No cartridge damage was observed.The cartridge did not have evidence that is was fully seated in a handpiece.Failure to seat the cartridge in a qualified handpiece may cause the lens or plunger to advance incorrectly.The handpiece information was not provided.It is unknown if a qualified model was used.Top coat dye stain testing was acceptable.(b)(4).

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6599041
• MDR Text Key: 76233587
• Report Number: 1119421-2017-00710
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K001157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 8065977758
• Device Lot Number: 32519227
• Other Device ID Number: 00380659777585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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: 70 YR