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

Catalog Number 8065977762

Device Problems Complete Blockage (1094); Physical Resistance/Sticking (4012)

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

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not 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.(b)(4).

Event Description

A physician reported during an intraocular lens (iol) implant procedure, the physician tried to push it but it still didn't penetrate because it was clogged in the cartridge.She experienced that it was rough inside surface and with resistance during advancement of lens despite generous amount of viscoelastic that was applied.A second iol and cartridge were used and an iol was successfully implanted.No harm to the patient.Additional information was provide that the event happened before implantation outside of the patient's eye, so the damaged iol did not come in contact with the patient's eye.

Manufacturer Narrative

Evaluation summary: the cartridge was returned.The cartridge does not have an iol stuck inside.An inadequate amount of viscoelastic was observed in the cartridge.The cartridge shows evidence it was placed into a handpiece.No tip damage observed.A qualified iol was returned adhered by solution to the fully assembled lens case base.Solution was dried on the lens.The lens was removed from the lens case base and cleaned with lphse for further evaluation.The optic has a small nick/chip on the anterior side of the optic and has a crack near the gusset area that runs towards the center of the optic.The cartridge product history records were reviewed and the documentation indicated the products met release criteria.A qualified viscoelastic was indicated.The cartridge and the lens were returned separated.The root cause for the reported event may be related to a failure to follow the directions for use.An inadequate amount of viscoelastic was observed inside the cartridge.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• 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: 8912247
• MDR Text Key: 155180685
• Report Number: 1119421-2019-01331
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K112977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

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: 06/30/2023
• Device Catalogue Number: 8065977762
• Device Lot Number: 32640712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN60WF 21.0 DIOPTER; SN60WF.210, ACRYSOF SP NATURAL IQ, HWV; UNSPECIFIED VISCOAT OVD, 000452, BEL; VISCOAT