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

Model Number AU00T0

Device Problem Insufficient Information (3190)

Patient Problems Intraocular Pressure Increased (1937); Prolapse (2475)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Surgeon explained that the patient¿s anterior chamber was unstable, and that he had experienced iris prolapse and raised iop.Surgeon commented that the lens may have been a factor in the complication but there were other possible factors.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A customer reported during implanting an intraocular lens (iol) using a preloaded delivery system, the haptic stuck on the top of the lens in the eye.Extra manipulation was required to free the haptic.The surgeon reports the patient's anterior chamber was unstable.The patient experienced iris prolapse and raised intraocular pressure (iop).The surgeon stated the lens may have been a factor in the complications.Additional information was requested but not received.

Manufacturer Narrative

Viscoelastic was not provided.It is unknown if a qualified product was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The surgeon explained that the patient¿s anterior chamber was unstable, and that he had experienced iris prolapse and raised iop.Surgeon commented that the lens may have been a factor in the complication but there were other possible factors.(b)(4).

• 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: 6421126
• MDR Text Key: 70480991
• Report Number: 1119421-2017-00400
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.210
• Device Lot Number: 12484768
• Other Device ID Number: 00380652358293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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): Other