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

Model Number SN6AT8

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/24/2015

Event Type  Injury  

Manufacturer Narrative

A product was not returned for evaluation.The product history record was reviewed and the documentation indicated the product met release criteria.The handpiece was not identified; it is unknown if it was qualified for the lens/cartridge combination used.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).

Event Description

Follow up information was received; it was informed that the experienced aseptic endophthalmitis in the left eye.The patient received treatment and was hospitalized, and recovered after treatment.

Manufacturer Narrative

(b)(4).

Event Description

A surgeon reported that fibrin was detected in a patient's eye noted at one day postoperative from intraocular lens implantation.Additional information has been requested for this report.

Manufacturer Narrative

Alcon is investigating an increased number of cases of aseptic endophthalmitis cases reported since (b)(6) 2015 in cataract surgery patients who received restor® iols in various clinics in (b)(6).We take this situation very seriously and in the interest of patient safety, are voluntarily recalling restor® multifocal iols manufactured specifically for the (b)(6) market and advising surgeons in (b)(6) whose clinics have inventory of restor® iols to stop using these iols.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.The manufacturer internal reference number is: 2015-20686.

Manufacturer Narrative

The identified lens in the initial report was not associated with a recall.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 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 japan.Acta ophthalmol.Scand 2007:85:848-851), we will continue to closely monitor for any potential trends or signals.(b)(4).

Manufacturer Narrative

Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of an approved monarch (c) cartridge.Monarch 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.Based on a review of complaints received, a signal for post-operative inflammation was identified for restor® iq and restor® toric iols in (b)(4).The manufacturing investigation pointed to the difference in manufacturing processes for the (b)(4) market and multifocal lenses as a potential differentiator.The manufacturing investigation has not identified a root cause to date.Data analysis so far has confirmed that these complaints are significant and concentrated around the (b)(4) market for the identified multifocal lenses.On april 13, 2015 the impacted product was put on voluntary hold in the (b)(4) market and issuance of the market caution letter.On april 16, 2015 due to a significant increase in reports of post-operative inflammation cases reported in cataract surgery patients who received the identified multifocal intraocular lenses (iols), a voluntary product recall was issued against all lot numbers and models of the identified multifocal iols manufactured specifically for the (b)(4) market.A corrective and preventive action has been instituted; the investigation is ongoing.The manufacturer internal reference number is: (b)(4).

Event Description

Follow up information was received; it was informed that the eye drug treatment was not changed at the onset of the eye condition.The patient received a subconjunctival injection in the left eye when hospitalized.Consequently, the patient was discharged, and when the patient returned for a follow up visit the "onset of the endophthalmitis was confirmed.A steroid injection was performed.The inflammation disappeared and symptoms were resolved.

• 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: 4756101
• MDR Text Key: 13972489
• Report Number: 1119421-2015-05253
• 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: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2016

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: 09/30/2019
• Device Model Number: SN6AT8
• Device Catalogue Number: SN6AT8Q175
• Device Lot Number: 12322803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 05/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/10/2015; 07/16/2015; 09/15/2015; 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2014
• 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 III D CARTRIDGE; UNSPECIFIED INJECTOR/HANDPIECE
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 69 YR