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

Model Number III

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

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

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

One handpiece injector was returned for evaluation.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.The injector was manufactured in (b)(6) 2009.A visual inspection of the handpiece injector was performed and deemed nonconforming.The plunger has a slight upward position.A functional thread to barrel engagement check was performed and was deemed acceptable.A dimensional plunger position height check was performed and deemed unacceptable.The plunger position height is high.The evaluation does confirm the injector plunger is bent slightly upward making the plunger position high.A high plunger position has a higher likelihood of overriding the lens and causing damage to the lens.The root cause for the nonconforming plunger height condition is usually from its handling by the end user or from its use over a long time period, but when and how the plunger became bent cannot be determined from this evaluation.The injector has been in service for approximately nine years, so the complaint issue does not point to a manufacturing issue.(b)(4).

Event Description

A nurse reported that when the surgeon injected the lens through the injector during a cataract removal with intraocular lens (iol) implant procedure, the trailing haptic got caught on the plunger of the injector handpiece and the trailing haptic broke off.The surgeon cut and removed the iol and a new iol was implanted.The procedure was completed on the same day, and no patient harm was reported.The reporter declined to provide any further information.

• 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: 7330562
• MDR Text Key: 102205938
• Report Number: 2523835-2018-00122
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 03/12/2018

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 Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 759839M
• Other Device ID Number: 380659777738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2018
• Initial Date FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other