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 Material Integrity Problem (2978)

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

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis; the lens remains implanted.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during five (5) cases of an intraocular lens (iol) implant surgery, the surgeon noticed a silicone-like residue on the cartridges.The surgeon was able to exchange the device and complete the case.Patient impact is unknown.Additional information has been requested.

Event Description

New information received from the customer stating the residue was only on the lenses but the surgeon states the cartridges are the suspect product.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The used company iii (d) complaint samples for lot #32651982 were not returned for evaluation.Forty-nine unopened company iii (d) cartridges were returned for the complaint lot # 32651982.This consisted of four unopened cartons (40 unopened) and one opened carton (9 unopened).One random unopened sample was pulled from each returned carton.The samples were numbered 1-5 for evaluation purposes.All five of the unused company iii (d) cartridge were microscopically examined and no foreign material was observed.All five of the unused company iii (d) cartridges were functionally tested per the dfu using a qualified company iii blue handpiece, company lens and company viscoat.The lens and cartridge were microscopically evaluated after each delivery.No foreign material was observed on any of the lenses.No damage or foreign material was observed in the company iii (d) cartridge.All five of the unused company iii (d) cartridge were cleaned and dye stain tested with acceptable results.No damage or missing coating was observed.The company product history records were reviewed and documentation indicates the product met release criteria.The associated lens model/diopters used were not provided.It is unknown if a qualified iols were used.The used company iii (d) cartridge complaint samples were not returned for evaluation.Only unopened/unused company iii (d) cartridges for lot #32651982 were returned.Five of the returned unopened samples were opened for evaluation.The samples were microscopically evaluated, functionally tested and top coat dye stain tested.No damage or abnormalities were observed.No foreign material was observed.No coating anomalies were observed.The lenses used during the functional testing were also evaluated after they were delivered.No foreign material or damage was observed.No problem was found.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
• MDR Report Key: 8270951
• MDR Text Key: 133969415
• Report Number: 1119421-2019-00091
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2019

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: 07/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32651982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 01/16/2019; 02/21/2019
• Supplement Dates FDA Received: 02/13/2019; 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVD: HEALON PRO