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 Problem Break (1069)

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

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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, the trailing haptic broke after the lens was implanted in the patient.The iol was removed and a second lens was attempted to be implanted using the same cartridge and injector, but the situation was the same.The surgery was completed after replacing the iol, cartridge and injector.It was reported there was no problem with the injector.The insertion feeling was different than usual and the cartridge is suspected to be the issue.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the used cartridge was returned.Inadequate viscoelastic is observed in the cartridge.The cartridge has evidence it was placed into a handpiece.The nozzle has stress.The tip has heavy stress and a small aneurysm.The cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.Cartridge product history records were reviewed and documentation indicated the product met release criteria.The indicated associated product are qualified for use with the cartridge.A video was provided of the surgery.The video showed inadequate viscoelastic placed in the cartridge.The trailing was observed at the optic edge instead of folded onto the optic surface.The lens was not biased down before being rapidly advanced.It also appeared that the forceps were turned sideways to advance the lens.Based on the video the plunger underride the lens misfolding the trailing haptic under the optic.The root cause appears to be related to a failure to follow the dfu.Based on review of the video, the trailing haptic was not folded in on the anterior optic surface when the lens was loaded.The lens was not biased down before it was rapidly advanced.As the lens is advanced into the eye, the plunger can be observed under the optic.The lens splits on the right and left side as the lens is advanced into the eye.The trailing haptic can be observed misfolded under the optic and broken.Per the dfu the trailing haptic should be folded in on the optic (diagrams are provided).The lens should then be biased down.Failure to conduct these steps may cause the lens to advance incorrectly causing damage.It also appeared the forceps were turned sideways to advance the lens instead of using the designed groove to hold the trailing haptic in position as the lens is advanced.In addition, an inadequate amount of viscoelastic was placed into the cartridge before loading the lens.The dfu instructs to fill the cartridge with viscoelastic before loading the lens.The cartridge tip was evaluated from the end no abnormalities were observed.Cartridge manufacturing is a validated operation, with specifications that are maintained and documented.The supplier manufacturing records as well as their certificate of compliance verify the dimensional measurements are within specifications.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
• MDR Report Key: 9623362
• MDR Text Key: 186151410
• Report Number: 1119421-2020-00110
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• 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: 04/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: 32722676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISCOVISC; MONARCH III IOL DELIVERY SYST; SN60WFA230, ACRYSOF SP NATURAL IQ, HWV; SN60WFA230, ACRYSOF SP NATURAL IQ, HWV