MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Material Rupture (1546)

Patient Problem Tissue Damage (2104)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned.The lens was returned taped to a piece of cardboard.Viscoelastic is dried on the lens.One haptic is broken-gusset not returned.The optic is cut through the center.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause for the reported events could not be determined by the product evaluation.Additional information indicated that capsule rupture was noted during iol insertion, not caused by it.There has been one other complaint reported in the lot number.Additional information was requested.A completed questionnaire was received.(b)(4).

Event Description

A purchasing agent reported that a preloaded intraocular lens (iol) was inserted in the eye and then had to be removed in the same procedure.In a follow up, a nurse clarified that during the iol insertion, the capsule was noted to be ruptured.The lens was removed through an enlarged incision.An anterior vitrectomy was performed, another lens was implanted in sulcus and sutures were used to close the wound.The surgeon does not blame the lens for the reported event.The event resolved with the indicated treatment.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6641948
• MDR Text Key: 77603753
• Report Number: 1119421-2017-00811
• Device Sequence Number: 1
• Product Code: KYB
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• 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: AU00T0
• Device Catalogue Number: AU00T0.200
• Device Lot Number: 12440270
• Other Device ID Number: 00380652358279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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
• Patient Age: 67 YR
• Patient Weight: 75