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

Model Number SN6AT9

Device Problem Material Rupture (1546)

Patient Problems Endophthalmitis (1835); Hyperemia (1904); Blurred Vision (2137); Rupture (2208)

Event Date 09/27/2015

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.The lens remains implanted.Product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information was requested and received.(b)(4).

Event Description

A doctor reported endophthalmitis following an intraocular lens (iol) implant procedure.The patient experienced hyperemia and blurred vision.The patient was treated with injections, followed by anterior chamber irrigation.The symptoms resolved.The doctor also reported a complication of upper zinn's rupture that occurred during the procedure.Product sample is unavailable for return as it remains implanted.Bacterium inspection information was not performed.There are two medical device reports associated with this event.This report is for the second eye.

Manufacturer Narrative

Alcon is conducting an ongoing investigation of reports of post-operative inflammation that were reported in cataract surgery patients implanted with restor and restor toric family of iols in (b)(6) since mid-january 2015.In the interest of patient safety, all restor and restor toric iols were voluntarily recalled from the (b)(6) market on 15-apr-2015 and surgeons in (b)(6) were advised not to implant the restor and restor toric family of iols.Following this recall, an increase in the number of cases of post-operative inflammation were reported for acrysof® iq toric iol models sn6at6, sn6at7, sn6at8 and sn6at9.Therefore, on september 29, 2015 the voluntary recall was expanded to include these additional lens models.Evaluation summary: the customer indicated the use of an approved cartridge with 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 customer indicated the use of a qualified viscoelastic.

Manufacturer Narrative

Event Description

Additional information was provided that the patient experienced eye pain and vitreous clouding.Bacteriological testing was performed and was negative.Symptoms recovered after 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: 5187977
• MDR Text Key: 29834159
• Report Number: 1119421-2015-06508
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: SN6AT9
• Device Catalogue Number: SN6AT9Q195
• Device Lot Number: 12280555
• Other Device ID Number: 00380652316798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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: 4% XYLOCAINE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR