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 Problems Crack (1135); Material Split, Cut or Torn (4008)

Patient Problems Corneal Abrasion (1789); Visual Disturbances (2140)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

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.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that marks described as surface abrasions were noted on an intraocular lens (iol) after it was implanted with a cartridge into a patient's eye.The patient experienced seepier vision compared to the other eye with the same lens model.The iol was explanted during a secondary procedure.Additional information was received indicating the patient also experienced washed out, brownish and degraded vision prior to the iol exchange.The doctor commented the cartridge was cracked and had signs of splitting.The iol abrasions do not appear like they are from forceps and nurse doesn¿t touch central optic when loading iol.The doctor also commented lens abrasions may possibly be from being quick in surgery with ¿ejecting lens very quickly and now allowing time for iol to settle in cartridge for tunnel size of plastic to shrink down¿.Comments that he notices cartridge expanding slightly on iol insertion with higher powered iol's.Also comments nurse may be a bit rough with loading but has discussed this with nurse and feels due to experience of nurse, this is unlikely cause of central iol abrasions.

Manufacturer Narrative

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

Manufacturer Narrative

Product evaluation: the cartridge was not returned for evaluation.The indicated iol was not returned for evaluation.A photo was provided.The photo is a close-up of the eye/pupil area.The center of the pupil has two groups of ¿lines¿.It is unclear which area is the area of interest.The first area has very small, closely grouped, whitish ¿lines¿.This area could be consistent with a scuff mark (the lines are angled up and to the right).It cannot be determined if these ¿lines¿ are on the lens.The second area has ¿lines¿ with a yellowish tint that run vertically.These could be consistent with fold lines or could be reflections.The photo does not allow for a determination.The travel path for the possible damage cannot be determined without visualization of the haptic/optic junction.Root cause: the root cause for the reported cartridge and iol damage could not be determined.Neither product was returned for evaluation.The provided photo has areas observed which may be consistent with a scuff or fold lines on the optic.However, no determination could be made from the photo.Information was provided that the surgeon commented the lens abrasions may possibly be due to being quick in surgery with ¿ejecting lens very quickly and not allowing time for iol to settle in cartridge".Fold lines may occur if the lens is advanced too rapidly.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: 10240738
• MDR Text Key: 197929885
• Report Number: 1119421-2020-00943
• 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: 09/23/2020

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: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/09/2020; 08/31/2020
• Supplement Dates FDA Received: 08/03/2020; 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DFT015 24.0 ACRYSOF VIVITY; GRIESHABER OR KELMAN FORCEPS USED; MONARCH III IOL DELIVERY SYST; PROVISC VIS SOLUTION 0.85ML
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR