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

Model Number SN6AT3

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Failure of Implant (1924); Visual Impairment (2138)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A company representative reviewed the provided photos.Images show pseudophakic eyes (unable to identify the implanted iol models from the pictures).The image is focused mainly on the iol body, multiple light scattering artifacts (spots) can be observed, these spots are of variable diameter, the diameter cannot be determined accurately.In addition it is observed a whitening of the capsulorhexis remnant.The product investigation could not identify a root cause for the reported issue.Although a definitive conclusion cannot be determined based solely on static pictures, the observations may be compatible with glistenings and/or inflammatory cells deposits on iol surfaces, and anterior capsule opacification.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

An ophthalmologist reported that approximately two months following an intraocular lens (iol) implant procedure, white dots were confirmed on the surface of the iol.Additional information has been requested.Additional information was provided that the patient fully recovered with steroid and antibiotic eye drops.The patient had experienced decreased visual acuity.A yag was applied to the iol surface unlike normal.There are two medical device reports associated with this patient.A previous report 1119421-2018-00666 had been filed for the fellow eye.

Manufacturer Narrative

This supplement is being filed to correct the value to adverse event and product problem.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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7658491
• MDR Text Key: 113019969
• Report Number: 1119421-2018-00849
• 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: Home Health Aide
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3Q210
• Device Lot Number: 12370589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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; Required Intervention
• Patient Age: 72 YR