MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number SN6CWS

Device Problem Insufficient Information (3190)

Patient Problem Endophthalmitis (1835)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and 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.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmic surgeon reported that on the fourth day following an intraocular lens (iol) implant procedure, a patient developed postoperative endophthalmitis and a flat anterior chamber.The inflammation has spread to the vitreous humor.The cause of the symptoms is unknown.The patient's current condition is unknown as patient was transferred to another facility.The lens remains implanted.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: a voluntary recall of acrysof restor® and restor® toric iol models occurred on (b)(6) 2015, after an increased number of complaints of ocular inflammation post cataract surgery.Following the announcement of the recall, reports of post-surgical ocular inflammation for non recall lenses in (b)(4) were also received.It is not unusual to expect the number of complaints to increase following such an announcement as there is heightened awareness of the event.The increase in complaints observed for the non recall models is specific to the (b)(4) market.Based on the interpretation that this increase in the number of reports of post-surgical ocular inflammation for the non recall models is below the published rates (oshika t, et al.Incidence of endophthalmitis following cataract surgery in japan.Acta ophthalmol.Scand 2007:85:848-851), we will continue to closely monitor for any potential trends or signals.(b)(4).

Manufacturer Narrative

Evaluation summary: the product was not returned.The product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5141992
• MDR Text Key: 27982606
• Report Number: 1119421-2015-06391
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 01/26/2016

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 Expiration Date: 01/31/2020
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWSQ215
• Device Lot Number: 12350924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2015; 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• 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
• Patient Outcome(s): Other