MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR

Model Number III

Device Problem Burst Container or Vessel (1074)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/11/2018

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.(b)(4).

Event Description

A nurse reported that a cartridge burst during implantation of an intraocular lens.The patient experienced a partial capsular tear.The patient needed an anterior vitrectomy.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

New information received from the sales representative stating the intraocular lens was implanted.

Manufacturer Narrative

(b)(4).

Event Description

New information received from the customer stating the surgeon suspected the company shooter.She exchanged the shooter and had to use a new lens to complete the case.The surgeon suspects the temperature may be a factor as the surgery room is very cold, as this is the only parameter which has changed.Now she pre-warms the lenses and since then, less complications have occurred.

Manufacturer Narrative

Company injector was returned for evaluation for the report of the cartridge bursting, resulting in a partial capsule tear.Photos were provided of the injector.A review of the device history record traceable to the reported lot number has been performed.The device history record review indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there was one additional complaint for the reported issue, from the same entity.The handpiece injector was manufactured in may 2010.The two photos provided with the complaint were reviewed.Photo 1 and 2 both show a picture of the blue injector.The lot number can be viewed and does match the complaint reported lot.A visual inspection of the iol handpiece injector was performed and was deemed conforming.A functional thread to barrel engagement check was performed and deemed conforming.A dimensional plunger position height check was performed and deemed conforming.The evaluation does not confirm the injector was the cause of the cartridge bursting.The injector met specification.The root cause of how the cartridge became damaged and burst cannot be determined from this evaluation.The surgeon believes the surgical theatre is very cold and may be a contributing factor for the delivery issue.Viscoelastic used was also aurovisc, a brand other than company recommended.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7225965
• MDR Text Key: 98484064
• Report Number: 2523835-2018-00038
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 806232M
• Other Device ID Number: 380659777738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 78 YR