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

Model Number SN60WF

Device Problem Difficult to Insert (1316)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 07/06/2015

Event Type  Injury  

Event Description

A surgeon reported that as an intraocular lens (iol) was being inserted into a patient's eye, a posterior capsular tear was noticed.The lens was removed, a vitrectomy was performed and another lens was implanted into the anterior chamber.Additional information was requested.

Manufacturer Narrative

A sample device 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.Attempts have been made to obtain additional information by phone and fax.A completed questionnaire was not received.(b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 4951333
• MDR Text Key: 22157867
• Report Number: 1119421-2015-05962
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2015

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: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.230
• Device Lot Number: 12292496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2014
• 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
• Patient Outcome(s): Required Intervention