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

Model Number III

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that the haptic of the intraocular lens implant broke after it was inserted in the injector and placed in the left eye.The incision size was increased.The implant was removed and replaced with an anterior chamber intraocular lens.

Manufacturer Narrative

An opened handpiece was returned for evaluation for the report of the haptic of the implant broke in patient's eye.A review of the device history records traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The handpiece was visually inspected and 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 complaint evaluation does not confirm the injector was the root cause for the broken haptic.The returned sample was found to be conforming for all visual inspection, dimensional and functional testing associated with the reported event.The reason for the complaint issue cannot be determined from this evaluation.Possible causes for a broken haptic are using the incorrect lens or cartridge with the incorrect injector, using an unapproved, improper temperature, or insufficient quantity of viscoelastic material, and the incorrect placement of the lens into the cartridge or incorrect cartridge placement into the handpiece injector.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Early post-operative corneal edema was noted.

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 10619325
• MDR Text Key: 209564208
• Report Number: 2523835-2020-00216
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 236225M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH CARTRIDGE; MONARCH ID CARTRIDGE; PROVISC; PROVISC; SN60WF IOL; MONARCH CARTRIDGE; PROVISC; SN60WF IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR