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

Model Number SN6AT6

Device Problem Material Rupture (1546)

Patient Problem Inflammation (1932)

Event Date 05/14/2015

Event Type  Injury  

Event Description

An ophthalmologist reported a patient developed endophthalmitis follow an intraocular lens (iol) implant procedure.Bacteria was detected.The lens remains implanted.Additional information was received from the surgeon, who reported that the zinn zonular ruptured during the surgery.On the third post-operative day, an antibacterial agent was administered.A bacterium inspection was performed with a (b)(6) result.The patient recovered approximately one month after surgery.Additional information was later received from the surgeon, who reported that the causality was unrelated.The type of bacteria cultured cannot be identified.

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis; the lens remains implanted.The product history and batch records were reviewed and 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.Additional information was requested and received.

Manufacturer Narrative

Evaluation summary: the customer indicated the use of an unspecified cartridge and an unspecified handpiece.The cartridge and handpiece 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.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)(6) 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)(6).Acta ophthalmol.Scand 2007:85:848-851), we will continue to closely monitor for any potential trends or signals.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information was provided by the surgeon, who reported that on the third postoperative day the patient also experienced keratic precipitates, anterior chamber cells, anterior chamber flare and fibrin.The patient was treated with a steroid medication and intravitreal injections.The symptoms recovered after the initial medical treatment.

• 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 ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4889133
• MDR Text Key: 15898684
• Report Number: 1119421-2015-05735
• 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
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6Q220
• Device Lot Number: 12330984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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: MONARCH HANDPIECE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR