MAUDE Adverse Event Report: ALCON RESEARCH, LTD / HUNTINGTON MONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D; LENS GUIDE

Catalog Number 8065977763

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Blurred Vision (2137)

Event Date 10/21/2014

Event Type  Injury  

Event Description

A surgeon reported that following intraocular lens (iol) implant surgery, a pt experienced endophthalmitis.The pt presented to the office with "black spots and cloudy vision", visual acuity was 20/50+, intraocular pressure was 18mmhg and 3+ cells with no hypopyon.The next day the pt returned to the office with hand motion vision and hypopyon.The pt was referred to a retinal specialist for cultures which grew out staphylococcus epidermidis.It was noted that during the first week of his post-operative care the pt was out cutting grass and had gotten some in his eye, along with some saw dust.Additional information was received from the surgeon, who reported that the infection has resolved.The pt may need a vitrectomy for derris and macular pucker and received intravitreal injections of antibiotics from a different physician.

Manufacturer Narrative

Complaint history and cartridge 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.Root cause has not been identified.Additional information was requested by phone and mail.A completed questionnaire was received.(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D
• 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: 4364335
• MDR Text Key: 16557742
• Report Number: 1119421-2014-01048
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/22/2014
• 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: (B)(4); VISCOAT; ILEVRO; DUREZOL; TOBRAMYCIN
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73