MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT4

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inflammation (1932)

Event Date 03/13/2015

Event Type  Injury  

Event Description

A customer reported post operative aseptic endophthalmitis after intraocular lens implant right eye and fibrin was detected around the implant.The patient was treated with anti inflammatory medicine and antibiotic medicine.Upon follow up it was informed that the patient's condition has improved.There is no product sample available for this event as the implant is still in the eye.

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.(b)(4).

Manufacturer Narrative

A product sample was not returned for evaluation.The product's history record was reviewed and the documentation indicated the product met release criteria.Based on a review of complaints received, the manufacturing investigation has not identified a root cause to date.An internal investigation has been opened to address reports of a similar nature.(b)(4).

Manufacturer Narrative

Additional information: the customer indicated the use of an approved cartridge.The cartridge's 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 customer indicated the use of a viscoelastic and handpiece, which is not qualified for the lens/cartridge combination used.A voluntary recall of acrysof restor® and restor® toric iol models occurred on april 16, 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 (b)(4).Acta ophthalmol.Scand 2007:85:848-851), we will continue to closely monitor for any potential trends or signals.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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 ; mail stop ab2-6; mail stop r3-48; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4748572
• MDR Text Key: 5706197
• Report Number: 1119421-2015-05226
• Device Sequence Number: 1
• Product Code: MJP
• 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,foreign,health professi
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4Q255
• Device Lot Number: 12274552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2014
• 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: PROVIDONE IODINE; HEALON; MONARCH HANPIECE; XYLOCAINE 2%; BASIC SALINE SOLUTION PLUS; CARTRIDGE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR