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 Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  Injury  

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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the surgeon needed to force the lens to implant it.Additional information has been requested.

Manufacturer Narrative

Additional information provided in a.1., a.3., b.2., b.3., b.5., d.11., h.1., and h.6.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received stating the patient has experienced a posterior capsular tear and the lens was subluxated during surgery.The surgery was completed on a secondary surgery when the surgeon implanted a new lens.

Manufacturer Narrative

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 file states the use of the monarch cartridge with a company lens.The company lens is only qualified for use in the company (a) and (b) cartridges for specific diopter ranges.The root cause for the reported event it most likely related to a failure to follow the dfu.The customer used a nonqualified iol/company cartridge combination.The company lens is only qualified for use in the monarch (a) and (b) cartridges for specific diopter ranges.The use of nonqualified product combinations may lead to delivery issues and/or damage.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: 10884866
• MDR Text Key: 218540735
• Report Number: 1119421-2020-01755
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977762
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 12/07/2020; 01/31/2021
• Supplement Dates FDA Received: 12/07/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MA60AC IOL.; MA60AC IOL.; MONARCH II HANDPIECE.; UNSPECIFIED PROVISC.
• Patient Outcome(s): Required Intervention