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

Catalog Number 8065977758

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and 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 product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, the lol was loaded into the cartridge with viscoelastic and when starting to introduce the iol in 60% a fissure line was observed in the final third of the cartridge which caused the haptic to break.The procedure was completed with another lens of the same model with no problems.The patient is in perfect condition.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: only the associated iol was returned.The associated iol was returned pressed against one post of the lens case base.Solution is dried on both surfaces of the optic and haptics.One haptic tip is broken/ torn and not returned.The other haptic is scratched/marked rejectable.The optic is cracked/fractured and scratched/marked-rejectable with loose fibers.The optic edge is nicked/chipped-rejectable.The cartridge and the iol product history records were reviewed and the documentation indicated the products met release criteria.The handpiece used with the lens/cartridge combination is unknown.A qualified viscoelastic was used.The root cause for the reported 'fissure line' in the cartridge cannot be determined because the complaint cartridge was not returned for an evaluation.The reported associated iol haptic damage was observed.The manufacturer internal reference number is: (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, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8179025
• MDR Text Key: 130983013
• Report Number: 1119421-2018-01770
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K001157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977758
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN60WF 24.5 DIOPTER; VISCOAT