MAUDE Adverse Event Report: ALCON RESEARCH LTD. / HUNTINGTON MONARCH III IOL DELIVERY SYSTEM HANDPIECE; LENS GUIDE

Catalog Number 8065977773

Device Problem Scratched Material (3020)

Patient Problem Eye Injury (1845)

Event Date 10/07/2014

Event Type  Injury  

Event Description

A pharmacist reported that during intraocular lens (iol) implantation the injector that was pushing the iol was bent and slided incorrectly scratching the iol inside the cartridge.The scratch was reported to be deep but not on the visual axis.The iol was cut and removed from the eye through an enlarged incision.Iris alteration with incarceration in the incision was reported.Another iol was implanted.The affected eye was the right eye.No further information is expected.This is one of two medical device reports being filed for this event.

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.Additional information has been requested but not received to date.(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM HANDPIECE
• 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: 4626169
• MDR Text Key: 5591522
• Report Number: 1119421-2015-00139
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• 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: SW60WF, ACRYSOF SP NATURAL IQ; DUOVISC; MONARCH III "D" CARTRIDGES
• Patient Outcome(s): Other
• Patient Age: 84 YR