MAUDE Adverse Event Report: ALCON RESEARCH, LTD./ HUNTINGTON MONARCH UNK IOL DELIVERY SYSTEM CARTRIDGE C; LENS GUIDE

Device Problems Use of Device Problem (1670); Inaccurate Delivery (2339)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 08/26/2014

Event Type  Injury  

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, the haptic broke causing a posterior capsule (pc) rupture.In a follow up, the surgeon reported there was a forceful entry of the iol, causing the pc rupture.The pc rupture was large enough to prevent another iol from being implanted, leaving the pt aphakic.The surgeon also reported the broken haptic did not enter the pt's eye.An anterior vitrectomy was also performed during the initial procedure.The surgeon reported he does not think the correct cartridge size was used during the procedure.The surgeon reported the event resolved with treatment, and will try to fit the pt in a contact lens.The surgeon indicated an unapproved lens/ cartridge combination was used during the implant procedure.Additional info has been requested.There are two medical device reports associated with this event.This report is for the cartridge.The medical device report for the intraocular lens was previously reported under mfr report # 1119421-2014-00740.

Manufacturer Narrative

Eval summary: the complaint sample was not returned by the reporting facility.Complaint history and product history records could not be reviewed for the cartridge because the facility did not provide a lot number or any identification traceable to the mfg documentation.Product history records were reviewed for the iol and all documents indicate the product met release criteria.The account used an unapproved lens/cartridge combination.This lens model is only qualified for use in a different model cartridge.The product was not returned and not enough info was provided from the account for further investigation.Additional info indicated the account used an unapproved lens/cartridge combination.Additional info has been requested.(b)(4).

• Brand Name: MONARCH UNK IOL DELIVERY SYSTEM CARTRIDGE C
• Type of Device: LENS GUIDE
• Manufacturer (Section D): ALCON RESEARCH, LTD./ HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD./ HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4135939
• MDR Text Key: 4790536
• Report Number: 1119421-2014-00752
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SN60AT IOL; UNK VISCOELASTIC MATERIAL
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO