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

Model Number SN6AT7

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 10/10/2015

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.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 has been requested.(b)(4).

Event Description

A healthcare worker reported a haptic missing from an intraocular lens (iol) implant.As a result, cataract phacoemulsification without iol implantation was performed.A back up lens was not available at the time of surgery.

Manufacturer Narrative

Product evaluation: the product was not returned.A photo and a video were provided and reviewed.Product history records were reviewed and the documentation indicated the product met release criteria.The reported damage was observed in the photo and the video provided.No damage was observed to the lens case in the video.The lens did not appear to be handled.The root cause appears to be manufacturing related.If the lens becomes misaligned in the lens case, lens damage may occur.

Event Description

Additional information was provided that the surgery was completed with the same type of iol two weeks following the initial procedure.

Manufacturer Narrative

Product evaluation: the product was returned.The returned product matches video and photo damage.Product history records were reviewed and the documentation indicated the product met release criteria.The reported damage was observed in the photo/video and with the returned product the root cause appears to be manufacturing related.If the lens becomes misaligned in the lens case, lens damage may occur.

• 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: 5198467
• MDR Text Key: 30285957
• Report Number: 1119421-2015-06530
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7.240
• Device Lot Number: 12349056
• Other Device ID Number: 00380652276009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/14/2015; 01/07/2016; 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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